Manager - Regulatory Affairs

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 fast-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 appropriate implementation strategies

Independently lead regulatory projects and interact with health authorities to drive approvals and resolve queries

Collaborate closely with cross-functional teams and customers to meet regulatory and business objectives

Review technical documents including characterization reports and method validation data

Utilize regulatory systems such as Veeva RIM for documentation and submission management (preferred)

Ensure high levels of coordination, communication, and alignment within internal teams and external stakeholders

Provide strategic and forward-looking regulatory guidance to ensure compliance and competitive positioning

Key Skills & Competencies

Strong knowledge of global regulatory frameworks (US, EU, Canada, Asia & emerging markets)

Expertise in DMF filing and lifecycle management

Strategic thinking and decision-making ability

Excellent technical writing and documentation skills

Strong communication and stakeholder management skills

Ability to work independently and lead regulatory initiatives

Why Join Us at PolyPeptide Group

PolyPeptide Group offers an opportunity to work at the forefront of peptide-based therapeutics, one of the fastest-growing segments in the pharmaceutical industry. As part of a global CDMO, you will contribute to impactful projects, collaborate with international teams, and play a key role in shaping regulatory strategies for life-saving therapies.