Openings in Regulatory Affairs at Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high-quality medicines.
Amneal Pharmaceuticals is currently inviting applications for openings in its Regulatory Affairs division. Ideal candidates will hold an advanced degree in Pharmacy (MPharm or PhD.), preferably with a specialization in Regulatory Affairs or Pharmaceutics. The role demands hands-on experience in regulatory functions, particularly with complex pharmaceutical products intended for the US and EU markets. Candidates should possess a comprehensive understanding of regulatory strategy, dossier preparation and filing, as well as responding to regulatory deficiencies. Proficiency in drafting controlled correspondences and preparing meeting packages is also essential for this position.

Post : Manager, Regulatory Affairs (Pre Approval) | Injectable | USA Market

Job Description
• Prepare, Review and Finalize Regulatory strategies for Complex Products [injectables that includes Peptides, Microspheres, Liposomes, Nano-suspensions, Colloids etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for Regulated markets (US, CA and EU market).
• Draft, Review and Finalize Pre-ANDA/Pre-IND/ScA/Scientific meeting packages and follow up communications with health authorities.
• Draft and finalize controlled correspondences on complex issues.
• Draft, Review and Finalize Deficiency responses for Complex Products and 505(b)(2) Products.
• Review API and FP in-vitro characterization/sameness reports.
• DMF review for complex APIs as per the workflow.
• To collaborate and work closely with cross functional teams.
• To meet the management expectations w.r.t timelines and quality.
• To work closely within the team and provide training to new members on new regulatory requirements for Complex products.
• Suitably qualified individuals with strong Scientific and Regulatory background.

Candidate Profile
• Academic degree in Pharmacy (M. Pharm or PhD), with preferably specialization in Regulatory Affairs or Pharmaceutics.
• Experienced (minimum 10 years) in Regulatory Affairs and overall experience 12+ years.
• End to end complete understanding of Complex Products for US/ EU market right from Strategy, Filing, Deficiency response etc.
• Experienced in drafting controlled correspondences, Meeting packages etc.
• Experience being an active contributor to cross-functional teams and/or working in matrix organizations. High quality, critical thinking, process, and performance orientated; prioritizes activities and projects.
• Exercises good judgment on regulatory, quality, and technical related compliance issues. High personal integrity; trustworthy; strong compliance and quality mind-set.
• Solution orientated, strong sense of ownership and accountability.
• Collaborative, team-oriented approach, capable of working cross-functionally, and in a matrixed and integrated way.

Additional Information
Experience : 5+ years
Qualification : M. Pharm or PhD
Location : Ahmedabad City, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 15th July 2025