Assistant Manager - Regulatory Affairs

Premas Biotech

Gurugram District

On-site

INR 1,500,000 - 2,100,000

Full time

14 days+

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Job summary

Premas Biotech Pvt. Ltd. is seeking an experienced Assistant Manager – Regulatory Affairs to lead medical device regulatory activities in India. You will drive submissions, licensing, and registrations while ensuring compliance with regulatory standards.

The role involves handling CDSCO submissions, SUGAM portal activities, licenses, and post‑approval changes, with exposure to biologics as part of the role. Collaboration with cross‑functional teams is essential for timely approvals.

Qualifications

Hands-on experience in Medical Device Regulatory Affairs.
Experience with CDSCO submissions, licensing, and product registrations.
Exposure to biologics is desirable.
Familiarity with MDR 2017 and QMS documentation.

Responsibilities

Manage regulatory submissions, registrations and licensing for medical devices.
Prepare and review regulatory dossiers and technical documentation.
Handle CDSCO submissions, SUGAM portal, licenses and post-approval changes.
Ensure compliance with MDR 2017 and ISO 13485.
Coordinate with cross-functional teams for registrations and approvals.
Maintain regulatory documentation and support audits.
Monitor regulatory updates and implement changes timely.

Skills

Medical Device Regulatory Affairs

CDSCO regulations & SUGAM Portal

Regulatory filings & licensing

ISO 13485 & QMS

MDR 2017

Biologics knowledge

Education

B.Pharm / M.Pharm

B.Tech / M.Tech (Biomedical/Biotechnology)

M.Sc. Life Sciences or equivalent

Job description

Assistant Manager Regulatory Affairs

Company: Premas Biotech Pvt. Ltd.

Location: IMT Manesar, Sector 5, Gurugram, Haryana

Experience: 5–7 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 will be an added advantage.

Preferred Industry Background