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Sr. Regulatory Affairs Associate

Job responsibilities include compiling
and submission of abbreviated New Drug
Applications (ANDAs). Prepare and submit amendments to pending applications in
response to not approvable letters. Review
all submission-related documentation (batch
records, packaging records and analytical reports)
to ensure problems are identified and addressed concurrently. Interface with external consultants
on bioequvilence study efforts, legal counsel on
patent infringement issues. Provide regulatory
review on innovator products (patent and
exclusivity status and bioequivalence
study costing) for new product proposals. Communicate with FDA on Regulatory issues.
Handle miscellaneous regulatory functions and
special projects.

Requirements: BS degree with minimum
4 years of related work experience. Strong communication and PC skills.