Regulatory Affairs Manager

Job Title

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).

Requirements:

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.