Assistant Manager - Regulatory Affairs

Assistant Manager Regulatory Affairs

Company: Premas Biotech Pvt. Ltd.
Location: IMT Manesar, Sector 5, Gurugram, Haryana
Experience: 57 Years

About Premas Biotech

Premas Biotech Pvt. Ltd. is an innovation-driven biotechnology company focused on advancing life sciences through cutting-edge technologies and research solutions. The company specializes in biologics, molecular diagnostics, recombinant proteins, vaccine development, and the proprietary AXTEX-4D® platform for 3D cell culture, supporting cancer research, immunology, drug discovery, and precision medicine. Premas collaborates with global research organizations, pharmaceutical companies, and healthcare partners to accelerate scientific innovation and improve patient outcomes.

Job Description

We are looking for an experienced Assistant Manager – Regulatory Affairs with a strong background in Medical Device Regulatory Affairs. The ideal candidate should have hands-on experience in CDSCO regulatory submissions, licensing, product registrations, and regulatory compliance. Basic knowledge of biologics is desirable and candidates will receive exposure to biologics as part of the role.

Key Responsibilities

• Manage regulatory submissions, product registrations, and licensing activities for medical devices.
• Prepare and review regulatory dossiers, technical documentation, and supporting documents.
• Handle CDSCO submissions, SUGAM Portal activities, import/manufacturing licenses, and post-approval changes.
• Ensure compliance with Medical Device Rules (MDR 2017), ISO 13485, and applicable regulatory guidelines.
• Coordinate with cross-functional teams to support product registrations and regulatory approvals.
• Maintain regulatory documentation and support audits, inspections, and compliance activities.
• Monitor regulatory updates and ensure timely implementation.

Required Skills

• Hands-on experience in Medical Device Regulatory Affairs.
• Strong knowledge of CDSCO regulations, SUGAM Portal, regulatory filings, licensing, and product registrations.
• Working knowledge of ISO 13485, Quality Management Systems (QMS), and technical documentation.
• Exposure to Medical Device Rules (MDR 2017).
• Basic understanding of Biologics Regulatory Affairs.

Preferred Industry Background

• Medical Devices
• Pharmaceuticals
• Biotechnology
• Biologics
• Life Sciences

Candidates from Cosmetics, Food, FMCG, Nutraceuticals, Agro, or other non-life sciences industries will not be considered.

Educational Qualification

• B.Pharm / M.Pharm
• B.Tech / M.Tech (Biomedical/Biotechnology)
• M.Sc. Life Sciences or equivalent

To Apply: Send your updated resume to [email removed]