Assistant Manager, Regulatory Affairs
Assistant Manager, Regulatory Affairs
Refined job description
ROLE
– Prepare, scientifically review, coordinate, and finalize ANDA/NDA CMC modules for oral solid, oral liquid, injectable, and other dosage forms.
– Work on due‑diligence projects for US, EU, and Canada markets in accordance with business agreements.
– Manage pre‑approval portfolio, including original submissions, deficiency responses, final approval requests, and other submissions.
– Prepare project status updates, discussion slides, and white papers for escalation and decision‑making at various project stages.
– Assess change controls and provide necessary regulatory comments and approvals.
– Support development and updating of regulatory tools, checklists, and databases as required by the department.
REQUIREMENTS
– Knowledge of relevant regulatory guidelines and updates.
– Ability to perform under changing priorities, deadlines, and regulatory expectations.
– Strong technical writing, presentation, training, and effective communication/coordination skills.
– Positive learning orientation to quickly adapt to Amneal systems, regulatory affairs tools, and processes.
Full 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.