Job Description

• 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.

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