Department: Regulatory Affairs
Location: Ambernath
Reports To: Head – Regulatory Affairs
Education: B.Pharm / M.Pharm / M.Sc (Science)
Experience: 15–18 years in API Regulatory Affairs
About PolyPeptide Group
PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a rapid-growing market, offering products and services from pre-clinical to commercial stages. Its broad portfolio reflects opportunities in drug therapies across multiple areas, with strong exposure to metabolic diseases, including GLP-1.
Founded in 1952, PolyPeptide operates a global network of six GMP-certified facilities across Europe, the U.S., and India. Its shares (SIX: PPGN) are listed on the SIX Swiss Exchange.
Purpose of the Role
To lead and manage global regulatory projects,



ensuring successful filing, lifecycle management, and compliance of Drug Master Files (DMFs) across multiple regulatory markets. The role will support the transfer and management of global regulatory activities to the Ambernath regulatory team.
Job Description for Regulatory Affairs Manager
- Lead preparation, review, and submission of DMFs for global markets including US, EU (ASMF & CEP), Canada, China, Korea, and emerging regions
- Ensure compliance with global regulatory requirements and guidelines including USFDA, EMEA, CEP, and ICH
- Develop and execute regulatory filing strategies for synthetic, semi-synthetic, and peptide APIs
- Prepare and review deficiency responses in line with regulatory expectations and timelines
- Manage lifecycle activities of DMFs including amendments, variations, and post-approval changes across regions
- Handle business-critical changes and perform regulatory impact assessments with appr

📌 Manager - Regulatory Affairs (Ambernath)
🏢 PolyPeptide Group
📍 Ambernath