Senior
Manager Regulatory CMC
A pharmaceutical company located in Connecticut is
seeking a Senior Manager Regulatory CMC to provide support
for registration activities to the organization's Latin
American (LA) licensees. Obtain Certificates of Pharmaceutical
Product (CPP) and GMP certificates to support international
submissions. Interact with associated companies to develop
dossiers for use in LA. Interact with functional groups
in the associated companies to assure current and accurate
information is provided. Represent LA regulatory interests
on selected Product Teams.
1. Provide support to organizations LA licensees for
registration activities.
2. Develop Regulatory filing strategies and provide
alternative approaches to support manufactured products
and products in development.
3. Obtain Certificates of Pharmaceutical Product (CPP)
and GMP certificates to support international submissions.
4. Coordinate the development of dossiers with other
associated Companies and with functional groups to insure
accurate regulatory submissions.
5. Prepare and/or review concise, comprehensive summaries
for pertinent CMC sections of regulatory dossiers.
6. Review draft CMC documents to insure they meet domestic
and international needs and fulfill all necessary regulatory
requirements for either initiation of clinical trials
or marketing.
7. As appropriate initiate contact with vendors, manufacturers,
regulatory agencies, etc. to effect resolution to CMC
issues.
8. Provide regulatory CMC support for product maintenance
(i.e., prepare CMC section for international product
re-registrations, NDA Annual Reports, etc.)
9. Provide support to organization's affiliated companies
for all CMC issues as appropriate.
Requirements:
o The Senior Manager should have a total of at least
six (6) years pharmaceutical industry or FDA experience
preferably in a manufacturing and/or QC function. At
least four (4) of those years should be in a regulatory/CMC
function.
o Proficiency in use of computer databases acquired
through hands-on experience, and technical training
courses.
o Demonstrated proficiency in CMC regulations and guidelines
on an international as well as domestic basis.
o Demonstrated high level understanding of CMC content
and format for regulatory submissions.
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Regualtory
Publishing Specialist
A pharmaceutical company in Maryland is seeking a Regulatory
publishing specialist to assists the Head of the Publishing
Group. The incumbent will provide guidance to the organization
with respect to electronic and paper submission requirements
by working with Regulatory Affairs and project teams,
to gather, interpret, and support implementation of
submission requirements. Implements regulatory submission
publishing and production activities in addition to
publishing documents.
Major Duties and Responsibilities:
-Manages submission publishing activity tasks including
preparation, QC, tracking and archiving.
-Manages compilation of submission outlines and assembly
of electronic submissions.
-Provides expertise to product teams on the application
of electronic submission requirements to their specific
submissions.
-Assists in the design and implementation of electronic
publishing standards.
-Assists in update activities related to publishing
software.
-Collects and interprets global electronic submission
guidelines.
-Assists in the development of authoring templates and
procedures for document creation in the electronic document
management system.
-Represents Regulatory Operations on outside User Team.
-Assists the Associate Director in all areas of responsibility,
including interpreting and enforcing paper and electronic
regulatory submission standards, policies and operating
procedure requirements.
Education:
-Undergraduate degree (scientific discipline or computer
science preferable) with a minimum of 2 years of related
experience.
Experience:
Minimum of three years overall experience in the biopharmaceutical/biotech
industry and at least 2 years of direct experience with
regulatory submissions. Strong technical knowledge and
working skills of computer software including advanced
MS Word features. Experience with publishing tools (e.g.,
Core Dossier) and with electronic document management
systems (e.g., Documentum) within the pharmaceutical
industry. Superior organization skills are mandatory,
in addition to being detail oriented.
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Manager/Senior
Manager/Associate Director Regualtory Affairs CNS
A global branded progressive pharmaceutical company
is expanding and seeks a Senior Manager/Associate Director
Regulatory Affairs CNS in their Northern New Jersey
facility to support regulatory strategies & contribute
to its outcome within the CNS area. Advise and recommend
departmental operating procedures/policies to accomplish
better quality control, efficiency and productivity.
Define regulatory visions & strategies for achieving
that vision as well as engage and motivate team to buy
into vision and execute strategy. Contribute to development
results by providing regulatory leadership and supervision
as well as serving as the "subject matter expert"
with regard to regulatory issues.
BS, MS, MD, JD, PharmD or Ph.D. in the life sciences
highly desired with a minimum 8-10 years of regulatory
experience within the pharmaceutical industry related
experience (i.e., manufacturing, clinical marketed products,
etc.) preferably including some broader industry experience.
CNS experience preferred but will look other therapeutic
areas. Regulatory expertise within at least 1 related
area including clinical trial management, manufacturing,
non-clinical testing and marketed products together
with broad understanding & experience in the clinical
development process. Prior hands on experience in interacting
with the appropriate regulatory bodies. Have in-depth
knowledge of appropriate Code of Federal Regulations
& Regulatory Guidance Documents History of working
in complex team environments with numerous/diverse stakeholders.
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Senior
Director Regulatory Affairs (CMC)
A major branded pharmaceutical company centrally located
in New Jersey seeks a Regulatory CMC Senior Director.
The position requires expertise with FDA and international
regulatory agencies. Candidates must possess strong
leadership competencies and business perspective to
ensure that sound regulatory and compliance practices
are fully integrated in all studies CMC, clinical development
and post marketing activities. Position will direct
the activities related to regulatory support and regulatory
compliance for both new and marketed products. This
includes all CMC areas e.g. formulation, ingredients,
process, testing, and stability. Provide expert consultation
for technical solutions to complex problems, participate
in cross-functional teams and simultaneously manage
multiple products, projects and timelines.
PhD, PharmD and relevant certification preferred, and,
15+ years of hands-on technical experience (Manufacturing,
Lab, QC/QA, etc.) within the pharmaceutical industry
and at least 8 years regulatory experience that must
include International Regulatory Affairs.
Knowledge and/or medical education agency in relevant
therapeutic areas. Strong technical knowledge. Excellent
leadership abilities
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Associate
Director Regulatory Affairs (CMC)
A well known branded pharmaceutical company in the New
Jersey area is expanding and seeks a Regulatory CMC
expert to direct the activities related to regulatory
support and regulatory compliance for both new and marketed
products. This includes all CMC areas e.g. formulation,
ingredients, process, testing, and stability. Additionally
you will provide expert consultation for technical solutions
to complex problems, participate in cross-functional
teams and simultaneously manage multiple products, projects
and timelines. The position is responsible for the management
of regulatory professionals.
PhD, PharmD and relevant certification preferred, Bachelor's
degree preferably in a scientific discipline and,10+
years of hands-on technical experience (Manufacturing,
Lab, QC/QA, etc.); within the pharmaceutical industry
and at least 8 years regulatory experience that must
include International Regulatory Affairs. Potential
candidates must possess the knowledge and/or medical
education agency in relevant therapeutic areas. Have
strong technical knowledge and excellent leadership
and negotiation abilities.
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Manager/Senior
Manager/Associate Director Regulatory Affairs, Oncology
A global branded progressive pharmaceutical company
is expanding and seeks a Senior Manager/Associate Director
Regulatory Affairs Oncology in their Northern New Jersey
facility to support regulatory strategies & contribute
to its outcome within the Oncology area. Advise and
recommend departmental operating procedures/policies
to accomplish better quality control, efficiency and
productivity. Define regulatory visions & strategies
for achieving that vision as well as engage and motivate
team to buy into vision and execute strategy. Contribute
to development results by providing regulatory leadership
and supervision as well as serving as the "subject
matter expert" with regard to regulatory issues.
BS, MS, MD, JD, PharmD or Ph.D. in the life sciences
highly desired with a minimum 8-10 years of regulatory
experience within the pharmaceutical industry related
experience (i.e., manufacturing, clinical marketed products,
etc.) preferably including some broader industry experience.
Oncology experience preferred but will look other therapeutic
areas. Regulatory expertise within at least 1 related
area including clinical trial management, manufacturing,
non-clinical testing and marketed products together
with broad understanding & experience in the clinical
development process. Prior hands on experience in interacting
with the appropriate regulatory bodies. Have in-depth
knowledge of appropriate Code of Federal Regulations
& Regulatory Guidance Documents History of working
in complex team environments with numerous/diverse stakeholders.
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Associate
Director Drug Regualtory Affairs
A global branded progressive pharmaceutical company
is expanding and seeks a Senior Manager/Associate Director
Drug Regulatory Affairs in their North Carolina (RTP)
facility to support commercial and corporate marketed
product initiatives. Serve as a site Regulatory Affairs
CMC liaison for this location. Develop CMC dossiers
and registration strategies in support of commercial
objectives. Oversee the assessment of change proposals
for marketed products and serve as the US Regulatory
Representative on Commercial Change Control Committee.
Liaise and negotiate with FDA Review and Compliance
divisions as necessary and provide Regulatory support
during FDA pre-approval inspections.
B.S. degree in pharmacy, chemistry or a related discipline
required, advanced degree (MS, PhD) strongly preferred
with 5 or more years of Regulatory CMC experience specifically
supporting commercial operations. Prior experience interacting
directly with the FDA.
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Senior
Manager Regualtory Informatics
Senior Manager Regulatory Informatics
A global branded progressive pharmaceutical company
is expanding and seeks a Regulatory Affairs Informatics
Senior Manager in their northern New Jersey facility
to be responsible for the management of the Regulatory
Operations information management systems, including
the IND/NDA annual reporting processes, the clinical
information registration (NIH) and disclosure (PhRMA)
systems, the regulatory communications (Regtracker)
system, and eArchives. In addition, they shall be responsible
for managing collaborative relationships affiliates,
Alliance partners, and others, to ensure the appropriate
exchange and management of Regulatory information as
well as managing and ensuring the continued professional
development of direct reports. Develop and conduct training
sessions to ensure consistent utilization and maintenance
of RA Operations information systems.
Identify and implement process improvements to ensure
processes remain aligned with established business objectives
and industry best practices. Develop Regulatory operations
business procedures to ensure consistent application
of established processes and the appropriate management
of Regulatory information. Assess and implement process
improvements for Regulatory Operations systems to ensure
processes remain in alignment with department needs
and established business objectives Oversee training,
mentorship and professional development programs.
Bachelor's degree in scientific discipline required
(e.g., Life Sciences, Chemistry, Pharmacy or Pharmacology)
Advanced degree strongly preferred (e.g., MS, PhD, PharmD
D, or PhD in life sciences) Advanced technical knowledge
or regulatory systems and processes with 4-5 years of
regulatory affairs or operations experience including
1-2 years of pharmaceutical industry experience. Superior
presentation skills with the ability to present to all
levels of the organization including senior management
Strong verbal, written and interpersonal communication
skills with the ability to give/receive developmental
feedback.
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Manager,
Regulatory Affairs Labeling
Responsible for coordinating the initial creation and
subsequent revisions of CDSs, USPIs and other regional
labeling for assigned products. Ensures that CDSs, USPIs
and corresponding regional prescribing information provide
all essential information for the safe and effective
use of the product.
Major Duties and Responsibilities (including supervising
others):
1. Lead cross-functional teams in the development and
lifetime maintenance of the CDS, USPI and other regional
labeling for assigned therapeutic area(s)
2. Provide tactical guidance to Labeling Working Groups/Global
Labeling Committee regarding language, placement, and
regulatory content detail for regional prescribing information
and CDSs
3. Provide precedent searches and comparison matrices
4. Manage corporate review and approval of all CDSs,
USPIs and other regional prescribing information
5. Issue CDSs and monitor implementation across regions
6. Ensure consistency in prescribing information across
products and therapeutic areas
7. Ensure corporate quality standards for prescribing
information are met
8. Maintain repository of all labeling documents, ensuring
version control and document integrity of internal draft,
Agency-submitted and Agency-approved labels
9. Represent functional expertise at all relevant department
meetings
10. Participate in the development and maintenance of
policies, SOPs, and associated documents relating to
corporate oversight of regional prescribing information
11. Train process contributors on corporate labeling
practices
12. Provide comments regarding regional labeling guidance
changes
13. Liaise with senior management as needed to resolve
critical labeling issues
14. Ensure regional submission timelines are met as
appropriate
15. Provide guidance to the junior regulatory staff
as need arises
16. Perform functions of significant scope with minimal
supervision
17. Assist in other regulatory activities as required
Education:
BS/MS in a scientific discipline such as chemistry,
pharmacy, biology or biochemistry etc. Advanced academic
training is highly desirable.
Experience: A minimum of 4 years of increasing documented
success in regulatory affairs (preferably in labeling)
with an additional 5 years or more in a relevant field
of pharmaceuticals/biotechnology. Work experience in
a biopharmaceutical arena is highly desirable.
Experience working in a GMP pharmaceutical environmental.
Competent knowledge of FDA regulations (current Code
of Federal Regulations and FDA Guidance) and ICH guidelines
preferred. Thorough understanding of and demonstrated
ability to apply US/EU regulatory guidelines pertaining
to product labeling, and CIOMS III/ V guidelines.
Special Skills/Abilities:
1. Able to multi-task
2. Act quickly in response to management objectives
3. Self-motivated and proactive worker
4. Possess professional ethics
5. Excellent planning and organizational skills
6. Excellent oral and written communication skills
7. Proficiency in the use of Microsoft Word and other
software programs
8. Strong interpersonal /group skills with ability to
direct, motivate and influence others
9. Capable of working collaboratively with colleagues
in all functions. Team player
10. Proven leadership qualities and ability to negotiate
successful outcomes
11. Ability to appropriately assess risks and formulate
risk-management strategies
12. Ability to interpret, understand and comply with
domestic and international regulatory requirements
13. Ability to coordinate information from various
internal and external disciplines
14. Flexible in changing project priority
15. Attention to detail and accuracy
16. Exercise good judgment and operate with large degree
of independence regarding routine and non-routine assignments
17. Adaptability to changing regulatory environments
Job Complexity:
1. Familiar with drug development process. Knowledgeable
in the principles of global labeling.
2. Flexibility to work on issues of diverse scope and
apply knowledge gained to multiple tasks. Demonstrated
ability to identify issues and initiative to recommend
resolution strategy.
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Associate Director Regulatory Affairs CMC
A major branded pharmaceutical company centrally located
in New Jersey seeks an Associate Director of Regulatory
CMC to direct the activities related to regulatory support
and regulatory compliance for both new and marketed
products. This includes all CMC areas e.g. formulation,
ingredients, process, testing, and stability. Additionally
you will provide expert consultation for technical solutions
to complex problems, participate in cross-functional
teams and simultaneously manage multiple products, projects
and timelines. Position responsible for the management
of regulatory professionals.
PhD, PharmD and relevant certification preferred, and,
10+ years of hands-on technical experience (Manufacturing,
Lab, QC/QA, etc.) within the pharmaceutical industry
and at least 8 years regulatory experience that must
include International Regulatory Affairs.
Knowledge and/or medical education agency in relevant
therapeutic areas. Strong technical knowledge. Excellent
leadership abilities
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Manager/ Senior Manager Global Regulatory Affairs
CMC
A well known branded pharmaceutical company centrally
located in New Jersey seeks a Manager/Sr. Manager Global
Regulatory Affairs , CMC to be responsible for directing
the activities related to regulatory support and regulatory
compliance for both new and marketed products. This
includes all CMC areas e.g., formulation, ingredients,
process, testing, stability. Additionally you will provide
expert consultation for technical solutions to complex
problems, participate in cross functional teams and
simultaneously manage multiple products, projects, and
timelines.
Bachelors Degree - Any Certification, advanced degree
preferred with at least 5 years hands on technical experience
(Manufacturing, Lab, QC/QA etc.) within the Pharmaceutical
industry and at least 5 years regulatory experience
that must include International Regulatory Affairs.
Strong technical knowledge. Must possess excellent leadership
abilities, strong written and verbal communication and
negotiation skills.
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Associate Director Global Labeling
A well known branded pharmaceutical company centrally
located in New Jersey seeks an Associate Director of
Global Labeling to support, but not limited, the infectious
disease products. The purpose of the position is to
work with the project teams to prepare corporate, US
and EU other global labeling (prescribing information
and patient information) documents for new products
and to update labeling for marketed products. Other
responsibilities of this position are to ensure that
all new labeling and labeling changes are reviewed and
approved in compliance with GRA and company policies
and procedures. Participate on safety committees to
expeditiously review and approve all safety related
labeling changes. Preparation of labeling components
for submission to regulatory agencies, and participation
in labeling negotiations with agencies resulting in
product approvals or labeling updates. The position
also includes review of local labeling to assure compliance
with corporate labeling.
MS, PharmD or Phd required, along with a minimum of
5 years of regulatory experience in a Pharmaceutical
environment
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Manager Global Labeling
A well known branded pharmaceutical company centrally
located in New Jersey seeks a manager of Global Labeling
to work with the project teams to prepare corporate,
US and EU and other global labeling (prescribing information
and patient information) documents for new products
and to update labeling for marketed products . Other
responsibilities of this position are to ensure that
all new labeling and labeling changes are reviewed and
approved in compliance with global regulatory affairs,
company policies and procedures. Participate on safety
committees to expeditiously review and approve all safety
related labeling changes. Preparation of labeling components
for submission to regulatory agencies, and participation
in labeling negotiations with agencies resulting in
product approvals or labeling updates. The position
also includes review of local labeling to assure compliance
with corporate labeling.
PharmD or PhD. 3 years dealing with FDA on labeling
issues.
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Associate Manager Regulatory CMC
A major branded pharmaceutical company centrally located
in New Jersey seeks an Associate Manager to be responsible
for directing the activities related to regulatory support
and regulatory compliance for both new and marketed
products. This includes all CMC areas e.g., formulation,
ingredients, process, testing, stability. Additionally
you will provide expert consultation for technical solutions
to complex problems, participate in cross functional
teams and simultaneously manage multiple products, projects,
and timelines
B.S. in Chemistry, Biological Sciences, Pharmacy or
related discipline. At least 5 years hands on technical
experience in the pharmaceutical industry including
at least 2 years relevant regulatory CMC experience.
Strong written and verbal communication skills. Detail
oriented. Experience with different dose forms, regulatory
assessments of change authorizations and International
regulations. Self motivated.
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Associate Director Regulatory Affairs (CNS)
Regulatory Affairs
Northern NJ
A well known progressive expanding global pharmaceutical
company located in Northern NJ seeks a Regulatory Affairs
Manager to obtain, prepare, review and submit data and
documentation to regulatory agencies in support of company
objectives in accordance with regulatory requirements
Provide regulatory support and participate in project
development core teams
Responsible for managing routine regulatory submissions
and reviewing regulatory issues with functional area
Participate in the strategic planning process
Begin interactions with FDA and other regulatory agencies.
Provide FDA telephone contact reports, process correspondence
in a timely fashion, inform/update internal/external
project team members of FDA actions, comments or requests
Continue education relating to FDA practices to ensure
that the guidance and input provided is based on the
current regulatory environment
MS/BA/BS degree required in associate functional discipline
(Life Sciences, Chemistry, Toxicology or Pharmacology),
Advanced degree preferred
Minimum 4 years regulatory experience in the pharmaceutical
industry. Additional relevant pharmaceutical or industry-related
experience preferred
Good organizational and time management skills and must
have strong verbal, written and interpersonal communication
skills in order to work efficiently in a team environment
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Manager, Regulatory Affairs (CNS)
Regulatory Affairs
Northern NJ
A well known progressive expanding global pharmaceutical
company located in Northern NJ seeks a Regulatory Affairs
Manager to obtain, prepare, review and submit data and
documentation to regulatory agencies in support of company
objectives in accordance with regulatory requirements
Provide regulatory support and participate in project
development core teams
Responsible for managing routine regulatory submissions
and reviewing regulatory issues with functional area
Participate in the strategic planning process
Begin interactions with FDA and other regulatory agencies.
Provide FDA telephone contact reports, process correspondence
in a timely fashion, inform/update internal/external
project team members of FDA actions, comments or requests
Continue education relating to FDA practices to ensure
that the guidance and input provided is based on the
current regulatory environment
BA/BS degree required in associate functional discipline
(Life Sciences, Chemistry, Toxicology or Pharmacology),
Advanced degree preferred
Minimum 2 years regulatory experience in the pharmaceutical
industry. Additional relevant pharmaceutical or industry-related
experience preferred
Good organizational and time management skills and must
have strong verbal, written and interpersonal communication
skills in order to work efficiently in a team environment
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Senior Manager, Regulatory Affairs
Position Summary:
Reviews and evaluates regulatory documents, such as
clinical and commercial manufacturing documents, protocols,
reports and specifications for compliance with regulatory
agency requirements for drug products and prepares submissions
for regulatory agencies. Familiar with a variety of
pharmaceutical industry concepts, practices and procedures.
Relies on experience and judgment to plan and accomplish
goals. Performs a variety of complicated tasks.
Position Scope:
This position requires knowledge of US and ICH regulatory
requirements for both investigational and marketed drugs
products.
Responsibilities:
Originates and submits paper and electronic investigational
and/or marketing applications such as INDS, NDAa, and
related supplements, amendments. Prepares reports to
support projects.
Provides RA supervisory support for complaint handling,
is the primary RA representative for CAPA and quality
systems initiatives.
Reviews and approves changes to procedures, protocols,
specifications, master records, etc.
May serve as primary contact to FDA or other regulatory
agencies, including coordinating and participating in
meetings with regulatory agencies, exchange of summary
documents and agreements.
Provides Regulatory support for assigned project teams,
including assembly and submission of applications for
those projects.
May provide training and oversight of regulatory associates.
Monitors regulatory environment and communicates new
regulatory requirements/initiatives to appropriate managers
and individuals in the organization.
Experience: Strong CMC and regulatory compliance background
is required. Bachelors degree in a chemical or biological
science plus at least 5years pharmaceutical industry
experience; or equivalent combination of education and
relevant work experience.
Ability to generate creative solutions for complex
problems and deal with a variety of concrete variables
in situations where limited standardization may exist.
Ability to interpret a variety of instructions furnished
in written, oral, diagram, or schedule form. The individual
should demonstrate attention to detail.
To perform this job successfully, an individual should
have proficiency in a computer-oriented environment,
especially word-processing and ability to use other
kinds of software typically used in a Regulatory submissions
venue. To perform this job successfully, the individual
should have good verbal and written communication skills
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Senior Manager to Director Level, GRA
A major branded pharmaceutical company in central NJ
seeks a regulatory affairs professional to plan, compile,
review and distribute quality regulatory submissions
to meet Health Authority commitments and Corporate Goals.
Maintains compliance with corporate, divisional and
health authority policies/procedures and regulations
and assures adherence by direct reports. Serve as the
CMC representative departmental, project team and professional
meetings. Maintain current knowledge of regulatory standards
and practices, Corporate Policies and Procedures and
departmental SOPs.
Ensures all health authority commitments are recorded,
tracked and fulfilled in a timely manner. Responsible
for developing CMC strategies and tactics for securing
approval of new drugs and post-approval changes at earliest
possible date. Ensures regulatory strategy for compound
is reflected in internal communications and actions.
Routinely provides input into the development of CMC
and global regulatory departmental policies and procedures.
Manages all CMC regulatory activities with health registration
worldwide including submissions. Identifies, obtains
and compiles required documents from CMC source areas
for submissions. Evaluates the adequacy of the content
of CMC regulatory submissions and identifies deficiencies
requiring further resolution, including critical review
of compliance-related materials in accordance with the
global regulatory Quality Review process guidelines.
Prepares responses to requests for regulatory data.
Determines submission strategy required by proposed
CMC and labeling changes. Works independently to assist
team in development of tracking documents and follows
to assure projects are completed on time and is responsible
for assuring timely receipt of documents to meet deadlines
for regulatory submissions. Coordinate activities for
submission including tracking status of IND/IDD, NDA/PLA/ELA/BLA,
MAA, ROW. Prepares CMC regulatory sections of DDPs (if
appropriate), ensures alignment with regulatory strategy
for development candidates and/or product line, as well
as reviews and approves labels for CMC information,
as appropriate. Is familiar with the latest regulations,
guidelines and trends and is an independent resource
for regulatory advice both internally within regulatory
and externally to source areas. Is familiar with developments
in CMC and frequently serves as resource to internal
and external parties. Reviews development plan to coordinate
US and international submissions for most effective
use of corporate resources. Disseminate pertinent regulatory
information, i.e., new guidelines/regulations to Project
and Study Team members. Updates teams on upcoming events
and deadlines and ensures reflection in Team minutes,
if pertinent. Maintains ongoing dialog with source areas
to facilitate input into crucial decisions. Interacts
with health authority, directly or via Country Operations;
may make regulatory decisions.
Bachelors or equivalent plus 9 years related experience,
including 5 years relevant regulatory experience; or,
Masters or equivalent plus 7 years related experience,
including 4 years relevant regulatory experience; or,
Ph.D. or equivalent plus 4 years related experience,
including 3 years relevant regulatory experience.
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Associate Manager Regulatory CMC
A major branded pharmaceutical company centrally located
in New Jersey seeks an Associate Manager to be responsible
for directing the activities related to regulatory support
and regulatory compliance for both new and marketed
products. This includes all CMC areas e.g., formulation,
ingredients, process, testing, stability. Additionally
you will provide expert consultation for technical solutions
to complex problems, participate in cross functional
teams and simultaneously manage multiple products, projects,
and timelines
B.S. in Chemistry, Biological Sciences, Pharmacy or
related discipline. At least 5 years hands on technical
experience in the pharmaceutical industry including
at least 2 years relevant regulatory CMC experience.
Strong written and verbal communication skills. Detail
oriented. Experience with different dose forms, regulatory
assessments of change authorizations and International
regulations. Self motivated
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Regulatory Affairs Manager/ Senior Associate, Marketed
Products
A branded global pharmaceutical company in New Jersey
seeks a regulatory professional to review and approve
all advertising and promotional materials for assigned
marketed products to ensure compliance with FDA regulations.
Liaise with co-promotional partners and the DDMAC to
facilitate promotional and FDA reviews, respectively.
Responsible for maintaining labeling compliance for
marketing products including maintenance of a labeling
history and change control for assigned products. Provide
labeling component of NDA annual reports and Periodic
Safety Update Reports (PURS). Assure most current labels
are utilized in marketing/promotional materials. Responsible
for regulatory activities related to Phase IV clinical
trials. Specific areas of responsibility include protocol
review regulatory documentation for investigators, product
labeling and shipment of clinical trial drug supplies.
Bachelor's degree required in associated scientific
discipline (Life Sciences, Chemistry, Toxicology or
Pharmacology). Candidates must have scientific background
and understanding of pharmaceutical operations and regulatory
compliance requirements as it applies to advertising
and promotion of pharmaceuticals. Have a history of
working in complex team environments with numerous/diverse
stakeholders. Strong communication skills with ability
to give/receive feedback and build consensus. Knowledge
of FDA rules, regulations and guidelines; specific knowledge
of advertising, promotional and labeling.
Manager: 4-6 years of pharmaceutical experience; at
least 2 in the regulatory function - reviewing advertising/promotional
materials for prescription drugs or biologics ("hands
on product review"),
Sr Associate: 1-3 year(s) of pharmaceutical experience;
at least 6 months to 1 year in the regulatory function
- reviewing advertising/promotional materials for prescription
drugs or biologics ("hands on product review").
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Regulatory Affairs Coordinator Marketed Product
A branded progressive global pharmaceutical company
in New Jersey seeks a Regulatory Affairs Coordinator
to provide regulatory submission operations support
for both paper and electronic submissions. This position
will support the efforts for marketed products. The
individual will prepare regulatory submission packages
(IND, NDA, ANDA, DMF etc.) for peer review and prepare
final packages for submission to the appropriate regulatory
agencies. This activity includes preparation of all
necessary forms, pagination, duplication, tabbing, binding
and performing a quality control check of the package.
Final copies are then mailed in accordance with divisional
procedures and must meet all requirements. This individual
will update various data management systems and specification
documents resulting from submission/approval of amendments
and supplements.
BS with 2-3 years experience within the pharmaceutical
industry in regulatory affairs. Strong attention to
detail. Excellent organizational and communication skills.
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