Assistant Manager Regulatory Affairs

Amneal Pharmaceuticals; Sarkhej; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Amneal Pharmaceuticals is seeking an experienced regulatory affairs professional with 8-12 years of experience at senior levels to coordinate CMC modules for solid, liquid, injections, and other dosage forms. The role involves due diligence for US, EU, and Canada markets, managing pre-approval submissions, and preparing status updates for leadership review.

The candidate should demonstrate strong skills in technical writing, presentation, and training, with knowledge of nitrosamine risk

Qualifications

• M. Pharm. degree preferred for the role.
• 8-12 years experience at AM/DM level or equivalent.

Responsibilities

• Preparation, scientific review, coordination & finalization of CMC modules for various dosage forms.
• Engage in due diligence projects for US, EU & Canada markets.
• Manage pre-approval portfolio including submissions and deficiency responses.
• Prepare project status slides and white papers for escalation and decisions.
• Assess change controls and provide regulatory comments/approvals.

Skills

Regulatory affairs

CMC documentation

Project coordination

Regulatory submissions

Due diligence

Change controls

Technical writing

Presentation

Training

Nitrosamine risk assessment

Education

M. Pharm.

Tools

AI tools

Regulatory databases

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.