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:

1. 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.
2. Draft, review, and finalize Pre-ANDA, Pre-IND, and Scientific Advice (ScA) meeting packages.
3. Prepare and finalize controlled correspondences related to complex regulatory matters.
4. Draft, review, and finalize deficiency responses for Complex Products and 505(b)(2) submissions.
5. Review API and Finished Product in-vitro characterization/sameness reports.
6. Perform DMF reviews for complex APIs in line with established workflows.
7. Collaborate closely with cross-functional teams to ensure successful project execution.
8. Drive timely,



high-quality deliverables while meeting business and regulatory expectations.
9. Mentor and support team members by providing guidance on evolving regulatory requirements for complex products.

Preferred Candidate Profile:

1. Strong scientific and regulatory background with deep expertise in Complex Products.
2. End-to-end understanding of product development, regulatory strategy, filings, agency interactions, and deficiency management for US/EU markets.
3. Experience in drafting regulatory meeting packages and controlled correspondences.
4. Proven ability to work effectively in cross-functional and matrix organizations.
5. Solid analytical, problem-solving, communication, and stakeholder management skills.
6. Quality-focused mindset with a high level of integrity, ownership, and accountability.
7. Collaborative and team-oriented professional who thrives in a agile environment.

Interested candidates may apply through the Amneal Career Portal or share CV at [email protected] with a cc to [email protected]

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