Work as Regulatory Affairs Manager at Amneal Pharmaceuticals - M.Pharm or PhD Apply

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.

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.

Candidate Profile
• Suitably qualified individuals with strong Scientific and Regulatory background.
• 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 : minimum 10 years
Qualification : M.Pharm or PhD
Location : Ahmedabad City, Gujarat
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th May 2025