Deputy Manager, Regulatory Affairs

About the role

Deputy Manager, Regulatory Affairs at Amneal leads the regulatory strategy and submission activities for complex injectable products, including peptides, microspheres, liposomes, and nano‑suspensions, targeting US and EU markets. The role requires a Master’s in Pharmacy and 8–10 years of hands‑on experience in regulatory affairs for injectable dosage forms, with a proven track record in ANDA filings, deficiency responses, and meeting package preparation for the US FDA. The incumbent will draft and finalize pre‑ANDA/IND/ScA meeting packages, controlled correspondences, and deficiency responses, while reviewing API and FP in‑vitro characterization reports and DMF submissions for complex APIs. Working closely with cross‑functional teams, the Deputy Manager ensures regulatory compliance, quality, and timely delivery of submissions. The position also involves training new team members on evolving regulatory requirements and maintaining high standards of scientific rigor and compliance. Amneal values diversity, inclusion, and a collaborative culture, offering a dynamic environment for regulatory professionals to drive product success in global markets.

What you’ll do

• Develop and finalize regulatory strategies for complex injectable products.
• Draft, review, and finalize pre-ANDA/IND/ScA meeting packages.
• Prepare controlled correspondences and deficiency responses.
• Review API and FP in-vitro characterization reports.
• Conduct DMF reviews for complex APIs.
• Collaborate with cross-functional teams to meet timelines and quality.
• Train new team members on regulatory requirements.

What you’ll bring

• Master's in Pharmacy (M. Pharm or PhD) with regulatory focus.
• 8-10 years in regulatory affairs for injectable dosage forms, 12+ total.
• End-to-end expertise in complex products for US/EU markets.
• Proficient in drafting controlled correspondences and meeting packages.
• Strong scientific, regulatory, and compliance mindset.
• Team-oriented, ownership-driven, and quality-focused.

Nice to have

• Experience submitting meeting packages to US FDA.
• Familiarity with 505(b)(2) product submissions.

Skills

Education

Master's Degree