Job Role: Sr. Executive
Department: Regulatory Affairs
Location: Corporate Office, Ahmedabad
Job Description:
- Compile, prepare, review, and submit ANDA submissions and Amendments to FDA with the overall objective of avoiding major deficiencies and contributing to obtaining approval within the shortest possible timeframes.
- Maintain a comprehensive awareness of all regulatory activities related to assigned projects and ensure project deadlines and performance standards are established and met.
- Possess expertise and prior experience in OSD (Oral Solid Dosage) / Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage form ANDAs.
- Ensure the timely submission of all assigned projects.
- Review and prepare documents that meet the requirements set forth by the US FDA and are accepted for review without query or Refusal to Receive (RTR).
- Evaluate change controls and formulate strategies for correct filing categories with guidance from supervisors. Proactively report major project issues for resolution and agreement. Compile and submit critical post-approval supplements, such as CBE, CBE-30, and PAS as necessary.
- Collaborate closely with relevant departments during product initiations, R&D phases, ANDA/Bio Execution, and after the initiation of stability to ensure timely availability of all documents for submissions.
- Prepare and finalize controlled correspondence to the FDA on specific issues as needed for assigned projects.
- Assess deficiency letters immediately upon receipt from the FDA, perform a detailed gap assessment, and discuss with superiors to finalize the response strategy.
- Proactively raise major project issues to superiors for resolution and agreement.
- Maintain flexibility in work timings and intermittently be available for teleconferences as per the schedule of the US team.
- Evaluate final compositions for IIG (Innovator-Innovator Generic) and Proportionality criteria, and develop regulatory strategies to avoid issues with acceptability for filing.
- Thoroughly review API (Active Pharmaceutical Ingredient) Drug Master Files (DMFs) and share review comments with the purchasing department on time. Follow up with the purchase team or DMF holders directly as needed to ensure compliance with provided comments.
- Proofread and approve all OTC (Over-The-Counter) and Rx (Prescription) product labeling components.
Email us your resume at indiacareers@amneal.com