Manager of Regulatory Affairs
- Job ID:AFF/EC
- Date:11/12/2008
- Location:New Jersey
- State:New Jersey
- Degree:B.S./B.A.
- Salary Range:$100,000 to $124,999
- This salary range was selected from the CareersInPharmaceutical.com salary data list. See the "Additional Salary" or contact the Recruiter for actual salary and benefits.
- Additional Salary/Compensation:
- 15-20% Bonus Target
- Job Types:
-
Pharmaceutical Regulatory Affairs
Job Description
Manager of Regulatory Affairs, BS degree and at least five years of generic drug RA experience to include ANDA filings. Ground floor opportunity with a major branded drug firm.
Responsibilities include:
Management of Generic regulatory activities to achieve registration goals of generic drugs through interactions with Federal agencies to ensure generic products receive regulatory approval
1. Responsible for the regulatory strategy to register all generics products in the US, including communication of the regulatory requirements and providing guidance to the US Regulatory group on regulatory issues. Negotiates generic drug development plans with FDA and coordinates responses to questions raised by FDA in a timely manner during review of data submitted in support of generic approvals and their supplemental applications.
2. Maintains communication with and between US Regulatory Affairs, Global Regulatory Affairs, and the FDA/ Generics Drugs Team relating to obtaining generic drug approvals and maintaining approval status in the US. Represents US Regulatory Affairs as a member of the Generics Drug Team for evaluating and selecting development projects.
3. Responsible for importation of electronic documentation and assuring imported documentation is accurate, legible and complete and application submissions are generated efficiently to meet timeline submissions.
4. Authors company or departmental standard operating procedures addressing regulated processes as appropriate. Trains colleagues on US regulatory requirements as appropriate.
5. Provides input into strategic planning to achieve global, regional and departmental goals for generic project approvals and life-cycle management. Responsible for local and global cross functional coordination with Technical Operations, Quality, Regulatory Affairs and to meet pre- and post-approval regulatory requirements.
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