Deputy Manager – Regulatory Affairs

Job Title: Deputy Manager – Regulatory Affairs

Location: Ambernath, India

Job Type: Full Time

Reporting: Head of Regulatory Affairs, Ambernath

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 the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide's shares (SIX: PPGN) are listed on SIX Swiss Exchange.

Position Overview:

We are looking for a passionate and experienced Deputy Manager – Regulatory Affairs to join our RA team. The RA department operates as a global function within PolyPeptide, with site-specific teams reporting to the global director. The Deputy Manager role plays a pivotal part in the regulatory affairs (RA) function, bridging operational execution with strategic oversight. It is designed to cultivate leadership, technical expertise, and cross-functional collaboration, ensuring alignment with both compliance standards and business objectives.

Key Responsibilities:

Drug Master File (DMF) Management

• Prepare, review, and submit DMFs in compliance with global regulatory requirements including US (FDA), EU (ASMF and CEP), Canada, China, Korea, Brazil, and emerging markets.
• Maintain and update DMFs throughout their lifecycle, including change filings and regulatory correspondence.

Regulatory Strategy & Compliance

• Develop and implement regulatory strategies for generic synthetic, semi-synthetic, and peptide APIs.
• Ensure all submissions meet statutory and regulatory standards across regions.

Deficiency Response Handling - Prepare responses to the deficiencies received from customers and agency, ensuring clarity, completeness, and compliance with their expectations.

Electronic Submissions - Prepare and submit dossiers using eCTD format via CDER NextGen portal and CESP gateway.

Cross-Functional Collaboration - Collaborate with internal stakeholders like R&D, QC, QA, Production to align regulatory strategies with business goals and expedite approvals for critical changes.

Guideline Adherence - Stay updated and ensure compliance with USFDA, EMEA, CEP, and ICH guidelines.

Technical Document Review - Through review of the documents received from the cross-function teams as per the statutory requirements of agency.

Regulatory Database Management - Utilize Veeva RIM and document management systems for regulatory data management and tracking submissions.

Communication and Soft skills - Candidate should have good communication skills (spoken and written) for internal and external coordination with customers. Candidate should be able to work and communicate independently with internal/external clients in most of the matters.

Qualifications: B. Pharma / M. Pharma or M.Sc. in Organic Chemistry

Experience: 10-12 years in API Regulatory Affairs

Add-ons: Well versed with MS PowerPoint, word, excel, Visio, MS Teams, docuBridge, Veeva

Why Join Us at Polypeptide Group:

Polypeptide Group offers an exciting opportunity to work at the forefront of peptide-based therapeutics, a rapidly growing and innovative segment of the pharmaceutical industry. As a key member of PolyPeptide team, you will have the opportunity to contribute to a company that is dedicated to the success of its clients and the advancement of peptide science. Join us and be part of a global organization that is shaping the future of life-saving therapies.