Deputy Manager, Regulatory Affairs

Role & Responsibilities:
• Prepare, review, and finalize regulatory strategies for complex dosage forms including injectables, peptides, microspheres, liposomes, nano-suspensions, ophthalmic, otic, topical, and DDCP products for US and EU markets
• Lead regulatory strategy and execution for 505(b)(2) products across US and EU regions
• Draft, review, and finalize Pre-ANDA, Pre-IND, and Scientific Advice meeting packages for regulatory agency interactions
• Prepare and manage controlled correspondences on complex regulatory issues
• Draft, review, and finalize deficiency responses for complex and 505(b)(2) products
• Review API and finished product in-vitro characterization and sameness reports
• Perform DMF reviews for complex APIs as per established workflows
• Collaborate closely with cross-functional teams to support development, filing, and approval activities
• Ensure timely delivery and high-quality regulatory outputs aligned with management expectations
• Provide regulatory guidance and training to team members on evolving requirements for complex products

Qualification:
• Master of Pharmacy (M.Pharm) or PhD in Pharmacy with specialization in Regulatory Affairs or Pharmaceutics preferred

Experience:
• Minimum 8-10 years of experience in Regulatory Affairs for injectable dosage forms
• Overall professional experience of 12+ years in pharmaceutical regulatory functions

Skills:
• In-depth understanding of complex product regulatory strategies for US and EU markets
• Strong experience in end-to-end regulatory activities including strategy, filing, and deficiency responses
• Expertise in drafting controlled correspondences and regulatory meeting packages
• Strong critical thinking, decision-making, and compliance judgment abilities
• High level of ownership, accountability, and quality mindset
• Ability to work effectively in cross-functional and matrix organizations
• Collaborative, solution-oriented, and team-focused approach

About the Company:
Amneal Pharmaceuticals is a global pharmaceutical company committed to expanding access to affordable, high-quality medicines across a broad range of therapeutic areas. As an equal opportunity employer, Amneal values diversity, inclusion, and integrity, fostering a workplace culture that encourages collaboration, innovation, and regulatory excellence while upholding the highest standards of quality and compliance.