Assistant Manager, Regulatory Affairs

Preferred Qualification: M. Pharm.

Preferred Experience: 8-12 yrs (for AM/DM level)

• 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.