We're Hiring | Deputy Manager - Regulatory Affairs (Complex Products)

Join our Regulatory Affairs team and play a key role in developing regulatory strategies and submissions for complex products across the US and EU markets.

Location: Ahmedabad
Qualification: M.Pharm / PhD (Regulatory Affairs or Pharmaceutics preferred)
Experience: 12+ years overall, with significant experience in Injectable dosage forms and Complex Products

Key Responsibilities:
• Prepare, review, and finalize regulatory strategies for Complex Products, including Injectables, Peptides, Microspheres, Liposomes, Nano-suspensions, Ophthalmics, Otics, Topical Gels, DDCPs, and 505(b)(2) products for US and EU markets.
• Draft, review, and finalize Pre-ANDA, Pre-IND, and Scientific Advice (ScA) meeting packages.
• Prepare and finalize controlled correspondences related to complex regulatory matters.
• Draft, review, and finalize deficiency responses for Complex Products and 505(b)(2) submissions.
• Review API and Finished Product in-vitro characterization/sameness reports.




• Perform DMF reviews for complex APIs in line with established workflows.
• Collaborate closely with cross-functional teams to ensure successful project execution.
• Drive timely, high-quality deliverables while meeting business and regulatory expectations.
• Mentor and support team members by providing guidance on evolving regulatory requirements for complex products.

Preferred Candidate Profile:
• Robust scientific and regulatory background with deep expertise in Complex Products.
• End-to-end understanding of product development, regulatory strategy, filings, agency interactions, and deficiency management for US/EU markets.
• Experience in drafting regulatory meeting packages and controlled correspondences.
• Proven ability to work effectively in cross-functional and matrix organizations.
• Robust analytical, problem-solving, communication, and stakeholder management skills.
• Quality-focused mindset with a high level of integ

📌 Deputy Manager, Regulatory Affairs Ahmedabad
🏢 Amneal Pharmaceuticals
📍 Ahmedabad