Senior
Manager Regulatory 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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