Manager – Regulatory Affairs (CMC, US Sterile Products)
Location: Ahmedabad, Gujarat, India
Job Type: Full-Time | Regulatory Affairs
Job ID: 6389
Application Deadline: 30/01/2026
About Amneal
Amneal Pharmaceuticals is a global leader in pharmaceutical innovation, committed to delivering high-quality medicines across multiple therapeutic areas. The company emphasizes regulatory excellence, compliance, and patient safety, fostering an environment that promotes professional growth and leadership in global submissions.
Role Overview
Amneal is seeking a Manager – Regulatory Affairs (CMC) with expertise in pre-approval and post-approval regulatory activities for sterile injectable, ophthalmic, otic, and IV bag products in the US market. The role focuses on developing and implementing regulatory strategies, ensuring timely FDA submissions, and providing leadership in complex sterile product dossiers.
Key Responsibilities
Lead the preparation, review, and submission of INDs, NDAs, ANDAs, amendments, and biologic dossiers to the FDA.
Develop and implement regulatory strategies for CMC across multiple dosage forms, including sterile products using aseptic or terminal sterilization techniques.
Prepare FDA meeting packages, controlled correspondences, and responses for Pre-ANDA, Pre-IND, and Pre-NDA requests.
Ensure timely submission of regulatory documents by coordinating with cross-functional teams (R&D, QA, QC, ARD, Clinical, Labeling).
Evaluate change controls and determine appropriate filing categories; proactively identify and escalate critical regulatory issues.
Lead and mentor assigned resources, providing guidance on quality submissions and compliance with new or updated FDA/ICH guidances.
Maintain awareness of regulatory requirements, FDA updates, and ICH guidance, ensuring best practice implementation across projects.
Manage project timelines, regulatory performance standards, and documentation for assigned projects from development through approval.
Support post-approval submissions such as CBE, CBE-30, and PAS, ensuring regulatory compliance and alignment with FDA expectations.
Communicate effectively with US-based teams and participate in virtual meetings as required.
Required Skills
Regulatory submission & dossier filing | Advanced
Regulatory guidelines knowledge (FDA, ICH) | Advanced
CMC documentation | Advanced
Regulatory strategy development | Advanced
Health authority query response | Advanced
Product lifecycle management | Advanced
Change control & regulatory impact assessment | Advanced
Cross-functional communication | Advanced
Problem-solving & risk mitigation | Intermediate
Change management & documentation | Intermediate
Qualifications & Experience
Master’s Degree in Pharmacy, Life Sciences, or related field.
Strong hands-on experience in US sterile injectable, ophthalmic, otic, or IV bag products.
Proven expertise in pre-approval and post-approval FDA submissions, including IND, NDA, ANDA, and amendments.
Deep knowledge of FDA regulations, ICH guidelines, and CMC requirements.
Excellent leadership, communication, and project management skills.
Ability to work independently, prioritize tasks, and coordinate with global cross-functional teams.
Why Join Amneal
Lead complex regulatory projects for US sterile products.
Collaborate with cross-functional teams in a dynamic pharmaceutical environment.
Drive regulatory strategy development and mentor junior team members.
Opportunity to work with a global organization committed to compliance, innovation, and professional growth.
Location: Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat, 380015, India
Job Schedule: Full-Time
Category: Regulatory Affairs | Master’s Degree
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Kyiv |Lima Region :
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Midrand | South Africa |Nišava District :
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