- 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.