Assistant Manager, Regulatory Affairs

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Amneal Pharmaceuticals in Ahmedabad seeks an Assistant Manager - Regulatory Affairs (CMC) to lead ANDA/NDA CMC modules and pre-approval activities for global markets. You will coordinate cross-functional teams, review technical documents, and ensure compliance with evolving global guidelines.

The ideal candidate holds an M. Pharm with 8–12 years of regulatory submissions experience, strong technical writing, stakeholder management, and familiarity with US/EU/Canada requirements.

Qualifications

• M. Pharm. degree is required.
• Experience: 8–12 years at AM/DM level.
• Experience with US/EU/Canada regulatory submissions a plus.

Responsibilities

• Preparation, scientific review, coordination, and finalization of ANDA/NDA CMC modules for dosage forms.
• Manage pre-approval regulatory portfolios, including submissions and deficiency responses.
• Perform regulatory due diligence assessments for US, EU, and Canada markets.
• Review change controls and provide regulatory impact assessments and recommendations.
• Prepare project status updates, discussion decks, white papers, and regulatory documentation for key decisions.
• Collaborate with cross-functional teams and participate in project review meetings.
• Develop and improve regulatory tools, databases, and compliance checklists.
• Stay updated with global regulatory guidelines and agency expectations.

Skills

Technical writing

Stakeholder management

Regulatory knowledge

Cross-functional coordination

Nitrosamine risk

AI tools in regulatory

Education

M. Pharm.

Job description

We're Hiring | Assistant Manager - Regulatory Affairs (CMC)

Join Amneal Pharmaceuticals and be part of a dynamic Regulatory Affairs team driving submissions across global markets.

Qualification: M. Pharm.

Experience: 8-12 years (AM/DM level)

Key Responsibilities:

• Preparation, scientific review, coordination, and finalization of ANDA/NDA CMC modules for oral solids, oral liquids, injectables, and other dosage forms.
• Manage pre-approval regulatory portfolios, including original submissions, deficiency responses, and approval-related activities.
• Perform regulatory due diligence assessments for US, EU, and Canada markets.
• Review change controls and provide regulatory impact assessments and recommendations.
• Prepare project status updates, discussion decks, white papers, and regulatory documentation for key business decisions.
• Collaborate with cross-functional teams and participate in project review meetings.
• Develop and improve regulatory tools, databases, and compliance checklists.
• Stay updated with global regulatory guidelines and evolving agency expectations.

Preferred Skills:

• Strong technical writing and presentation skills
• Effective stakeholder management and cross-functional coordination
• Experience in Nitrosamine Risk Assessment review will be an added advantage
• Quick adaptability to regulatory systems, tools, and processes
• Knowledge of AI tools and their application in regulatory operations is desirable

If you are passionate about Regulatory Affairs and looking for an opportunity to contribute to global submissions and product approvals, we'd love to hear from you.

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