Deputy Manager Regulatory Affairs

As a Deputy Manager Regulatory Affairs at PolyPeptide Group, you will play a crucial role in bridging operational execution with strategic oversight, ensuring compliance with global regulatory requirements and contributing to the success of the company. **Key Responsibilities:** - **Drug Master File (DMF) Management** - Prepare, review, and submit DMFs in compliance with US (FDA), EU (ASMF and CEP), Canada, China, Korea, Brazil, and other emerging market regulations. - 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 deficiencies from customers and regulatory agencies, ensuring clarity, completeness, and compliance with expectations. - **Electronic Submissions** - Prepare and submit dossiers using eCTD format via CDER NextGen portal and CESP gateway. - **Cross-Functional Collaboration** - Collaborate with internal stakeholders (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** - Review documents received from cross-functional teams as per statutory requirements of agencies. - **Regulatory Database Management** - Utilize Veeva RIM and document management systems for regulatory data management and tracking submissions. - **Communication and Soft Skills** - Demonstrate good communication skills (spoken and written) for internal and external coordination with customers. Ability to work and communicate independently with internal/external clients in various 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 At PolyPeptide Group, you will have the exciting opportunity to work in the forefront of peptide-based therapeutics, contributing to the success of clients and the advancement of peptide science. Join us and be part of a global organization shaping the future of life-saving therapies.,