Assistant Manager, Regulatory Affairs

Amneal Pharmaceuticals · Ahmedabad

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.

• 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.

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