Regulatory Affairs Manager - Katalyst Healthcares & Life Sciences
San Jose, CA 94088
About the Job
Responsibilities:
- Regulatory submissions including Original ANDAs, Amendments, Annual Reports, Supplements and PADERs to company applications.
- Preparation/Review of Original submission/Amendments/ Supplements as assigned by the Director, Regulatory Affairs or VP, Regulatory Affairs.
- Participate in project calls with minimal supervision and work very closely with internal and external project managers, contract manufacturers to ensure timely availability of documents for submission.
- Review the submission documents for accuracy and adequacy and approach the management immediately for any questions or concerns.
- Stay updated on the Agency's expectations based on guidance's/ deficiencies and apply the same logic for future submissions to avoid any similar deficiencies.
- Ensure the facilities used in company's applications commit to GDUFA requirements (site identification, facility fees).
- Degree in Science with at least 10 years of experience in the pharmaceutical industry.
- Understanding of regulations relating to generic pharmaceuticals.
- Understanding of generic drug approval process and associate regulations.
- Capable of technical review of documents submitted in applications.
- Organizational skills and multi-tasking.
- Excellent written and verbal communication skills.
Source : Katalyst Healthcares & Life Sciences