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 quick-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 appro

📌 Manager - Regulatory Affairs (Ulhasnagar)
🏢 PolyPeptide Laboratories
📍 Ulhasnagar