Job Title: Regulatory Affairs Associate

Location: Bodh Gaya, Bihar, India

Job Type: Full-time | On-site

Company: Vastu Vihar Biotech Pvt. Ltd.

About Us:

Vastu Vihar Biotech Pvt. Ltd. is a biotechnology and research-driven organisation dedicated to developing innovative therapies for complex and chronic autoimmune diseases. The company focuses on advanced R&D; in exRNA- and ribozyme-based drug development to address unmet medical needs through novel biological approaches.

It actively engages in pre-clinical and clinical research for conditions such as asthma, psoriasis, chronic hepatitis, and other inflammatory diseases, integrating molecular biology, biotechnology, and translational science to develop next-generation therapeutics. With a strong emphasis on innovation and real-world impact, the company strives to create cost-effective and accessible treatment solutions through advanced laboratory infrastructure and multidisciplinary collaboration. We are committed to advancing global healthcare by delivering safe, effective, and science-driven therapies for hard-to-treat diseases.

About the Role:

Vastu Vihar Biotech Pvt. Ltd. is looking for an experienced and detail-oriented Regulatory Affairs Specialist to support regulatory compliance and documentation activities related to biotechnology, pharmaceutical, and research projects.The candidate will be responsible for preparing, reviewing, organizing, and maintaining regulatory documentation, coordinating with internal R&D; and quality teams, monitoring applicable regulatory requirements, and supporting submissions and approvals with relevant regulatory authorities.The ideal candidate should have at least 2 years of hands-on industrial experience in Regulatory Affairs, preferably within the pharmaceutical, biotechnology, life sciences, diagnostics, or research industry.

Key Responsibilities:

- Prepare, review,



and maintain regulatory dossiers, submissions, applications, and supporting documents.
- Monitor and interpret regulatory guidelines, notifications, standards, and compliance requirements.
- Coordinate with R&D;, QA, QC, Preclinical/Clinical, Manufacturing, and other teams for regulatory activities.
- Support regulatory submissions, registrations, renewals, amendments, licenses, and approvals.
- Review technical documents, SOPs, protocols, reports, and study-related documentation for regulatory compliance.
- Identify regulatory gaps and support corrective actions and responses to regulatory queries, observations, and deficiencies.
- Maintain regulatory trackers, submission records, correspondence, document control, and archival systems.
- Support regulatory audits, inspections, compliance assessments, and biotechnology/pharmaceutical research-related submissions.

Required Skills:

- Strong knowledge of Regulatory Affairs and regulatory compliance.
- Hands-on experience in regulatory documentation and submission preparation.
- Good understanding of pharmaceutical/biotechnology regulatory requirements.
- Experience in preparing and reviewing technical and regulatory documents.
- Ability to interpret regulatory guidelines and translate requirements into actionable tasks.
- Strong documentation, communication, coordination, and organizational skills.
- Valuable attention to detail and ability to manage multiple regulatory activities simultaneously.
- Proficiency in MS Office, documentation systems, and regulatory tracking tools.

Required Qualification:

- Master's in Pharmacy, Biotechnology, Life Sciences, Pharmaceutical Sciences, or a related discipline.
- Minimum 1 years of hands-on industrial experience in Regulatory Affairs.
- Candidates with experience in pharmaceutical, biotechnology, diagnostics, life sciences, or R&D; organizations are preferred.

📌 Regulatory Affairs Associate (Bodh Gaya)
🏢 Vastu Vihar Biotech
📍 Bodh Gaya