Regulatory Affairs & Biosafety Coordinator

Company: Premas Biotech Pvt. Ltd.

Location: IMT Manesar, Gurugram, Haryana

Department: Regulatory Affairs / Scientific Governance

Experience: 49 Years

Qualification: M.Sc./M.Tech./B.Tech. in Biotechnology, Molecular Biology, Microbiology, Biochemistry or related life sciences. Relevant regulatory affairs experience is essential.

About Premas Biotech

Premas Biotech is a biotechnology company focused on developing innovative technology platforms and biologics solutions. With expertise across recombinant protein expression, cell culture and antibody discovery, the organisation works at the intersection of scientific innovation and biomanufacturing.

Role Overview

We are looking for a regulatory qualified with experience in biotechnology, biologicals and biosafety-related regulatory coordination. The role will involve managing institutional regulatory documentation, coordinating biosafety-related committee activities, maintaining compliance records and facilitating communication with relevant regulatory authorities.

The ideal candidate should have practical exposure to Institutional Biosafety Committee (IBSC), Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology (DBT) and the Indian Biosafety Knowledge Portal (IBKP).

Key Responsibilities

1. IBSC & Biosafety Coordination

- Coordinate institutional biosafety committee activities, meetings and documentation.
- Facilitate preparation and circulation of meeting agendas, proposals, presentations and supporting documents.
- Maintain meeting minutes, decisions, recommendations and action-point trackers.
- Coordinate with internal scientific teams and relevant committee members for biosafety-related submissions.
- Maintain institutional biosafety records and ensure timely reporting and follow-ups.

2. Regulatory Submissions & Compliance

- Prepare, review and coordinate regulatory submissions to IBSC, RCGM and other relevant regulatory authorities.
- Manage submissions and reporting through the Indian Biosafety Knowledge Portal (IBKP).




- Track regulatory requirements, submission timelines, approvals, renewals and compliance obligations.
- Coordinate regulatory correspondence and maintain an organised repository of approvals, reports and supporting records.
- Support regulatory inspections, audits and compliance assessments.

3. Scientific & Technical Coordination

- Coordinate with research and development teams regarding recombinant DNA technology, genetically engineered organisms and biotechnology research activities.
- Ensure that relevant technical information and supporting documentation are available for biosafety review.
- Facilitate collection of information relating to biological risk assessment, containment requirements and laboratory practices from relevant scientific teams.
- Support documentation of biosafety-related SOPs, protocols and institutional procedures.

4. Documentation & Governance

- Establish and maintain systematic documentation and record-control practices.
- Monitor regulatory changes and communicate relevant updates to stakeholders.
- Maintain compliance calendars, submission trackers and committee action trackers.
- Support continuous improvement of institutional regulatory governance processes.

Required Skills & Competencies
- Hands-on experience with IBSC and/or RCGM-related regulatory activities.
- Working knowledge of IBKP portal and DBT biosafety regulatory framework.
- Understanding of recombinant DNA technology and genetically engineered organisms.
- Knowledge of biosafety principles, biological risk assessment and containment practices.
- Strong regulatory writing, documentation and record-management skills.
- Experience coordinating meetings, regulatory submissions and cross-functional stakeholders.
- Strong communication, follow-up and organisational skills.

Preferred Experience

- Experience in biotechnology, biologics, vaccines, biosimilars, genetic engineering or life sciences research organisations.
- Prior coordination of IBSC meetings, annual reports and regulatory submissions.
- Experience interacting with DBT, RCGM, IBSC or other relevant regulatory bodies.

📌 Regulatory Affairs & Biosafety Coordinator (Gurugram)
🏢 Premas Biotech
📍 Gurugram