MANAGER, REGULATORY AFFAIRS

  • Woodcliff Lake, NJ

Employment Type

: Full-Time

Industry

: Non-Executive Management



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Eagle Pharmaceuticals is seeking a motivated RA Manager. Primary responsibilities include supporting the compilation and composition of regulatory submissions, coordinating the required documentation and briefing documents and preparing new and revised Drug Listings.

Primary Responsibilities
-Support the compilation and composition of regulatory submissions including INDs, NDAs, ANDAs and FDA meeting requests and briefing documents to ensure all submissions meet FDA expectations as described in current guidance and comply with applicable regulations.
- Coordinate the required documentation and compose IND, NDA, ANDA and ODE Annual Reports, as needed, by working with cross-functional teams and external stakeholders to ensure compliance with established FDA timelines.
-Prepare new and revise Drug Listing as required.
- Support and coordinate label and labeling updates and revisions to ensure compliance with FDA requirements including 2253 submissions.
-Preparation and coordination of CPP requests to support Eagle s growth markets.
-Support the coordination of required documentation to support Eagle s growth market registrations.
-Maintain Regulatory Tracking lists to insure they are current and reflect the current activities of the department.
-Serve as a Regulatory Affairs representative on project teams and provide regulatory and technical input to cross-functional teams.
-Maintain awareness with key stakeholders regarding evolving regulatory requirements.

Requirements
-Bachelor s Degree in Life Sciences preferred.
-4-6 years regulatory experience and 1-2 years experience at a Manager level or equivalent.

Work Conditions
-Domestic and international travel as required.


Eagle Pharmaceuticals offers competitive pay, benefits and a flexible work environment. If interested, please apply on our website at .

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.


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