Assistant Manager, Regulatory Affairs

Amneal Pharmaceuticals India · Ahmedabad

Source and collection record

Last observed by our collector: 8 October 2026 at 11:04 pm IST. This is not a manual review or a confirmation from the employer.

Employer requisition: 8952

Job type and experience labels are automated discovery categories. The employer determines eligibility. Original experience wording was not retained separately; check the current employer page.

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Collected minimum qualification: Master's DegreeAttendance and availability: I checked the employer page for work location, office attendance, start date and duration.Current requisition: I checked the current employer requisition and its application requirements.

0 of 3 checks marked. Keep unresolved requirements as questions for the employer.

Collected role description

• Preparation, scientific review, coordination & finalization of ANDA/NDA CMC modules for oral solid, oral liquid, injectable & other dosage form as per the business goals. • Working on due diligence projects for US, EU & Canada markets as per the business agreement. • Managing pre-approval portfolio including original submission, deficiency response, final approval request & any other submissions. • Assessment of change controls & providing necessary regulatory comments/approval. • Knowledge of relevant regulatory guidelines & updates is must. • Skills like, technical writing, presentation, training, effective communication/coordination is preferred. Experience of Nitrosamine risk assessment report review will add value. Preferred Qualification: M. Pharm. Preferred Experience: 8-12 yrs (for AM/DM level) Job Description: Preparation, scientific review, coordination & finalization of ANDA/NDA CMC modules for oral solid, oral liquid, injectable & other dosage form as per the business goals. Working on due diligence projects for US, EU & Canada markets as per the business agreement. Managing pre-approval portfolio including original submission, deficiency response, final approval request & any other submissions. Preparation of project status, discussion slides & white papers as required for escalation & decision at different stages of the projects. Assessment of change controls & providing necessary regulatory comments/approval. Provide support in developing/updating regulatory tools, checklists, databases as per dept. needs. Participate in project meetings, communication & coordination with CFTs. Knowledge of relevant regulatory guidelines & updates is must. Ability to perform under changing priorities, deadlines & regulatory expectations. Skills like, technical writing, presentation, training, effective communication/coordination is preferred. Experience of Nitrosamine risk assessment report review will add value. A positive learning orientation to quickly adapt Amneal systems, RA tools & processes will add value. Knowledge of using AI tools in routine work will add value.

Collected minimum qualification

Master's Degree

Collected experience requirement

8-12 years