Assistant Manager, Regulatory Affairs
Amneal Pharmaceuticals · Ahmedabad
- Experience8–12 yrs
- SalaryNot disclosed
- Work modeonsite
- Levelexecutive
- Posted11 Sept 2026
About Amneal Pharmaceuticals
Amneal Pharmaceuticals is hiring in Ahmedabad in pharma biotech. This role looks for around 8+ years of experience.
Skills
- ANDA/NDA CMC modules
- Regulatory guidelines
- Change control
The role
A regulatory affairs manager at a pharmaceutical company prepares and reviews ANDA/NDA CMC modules for oral, injectable, and other dosage forms, manages submissions, and assesses change controls. Regulatory guidelines and technical writing support compliant product approvals and cross-functional project decisions.
Full job description
Job Description
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.