Regulatory Affairs Specialist

Position: Regulatory Affairs Specialist

Department: Regulatory

Location: Bodh gaya (Bihar), Varanasi (UP)

Employment Type: Full-Time (Onsite)

Experience: 3–8 Years

About the Role

The Regulatory Affairs Specialist is responsible for ensuring that the organization's products comply with all applicable national and international regulatory requirements throughout their lifecycle. This role supports the preparation and submission of regulatory dossiers, maintains compliance with evolving regulations, and serves as a key liaison between regulatory authorities and internal cross-functional teams. The Regulatory Affairs Specialist works closely with Research & Development, Quality Assurance, Manufacturing, Clinical, and Commercial teams to facilitate timely product approvals, registrations, and market access while ensuring adherence to regulatory standards and company policies

Key Responsibilities:

• Prepare, review, and submit regulatory dossiers for product registrations, renewals, amendments, and variations.
• Develop and maintain regulatory documentation in compliance with applicable guidelines and standards.
• Ensure compliance with regulatory requirements issued by agencies such as the FDA, EMA, CDSCO, MHRA, TGA, PMDA, and other global regulatory authorities.
• Coordinate with Research & Development, Quality Assurance, Manufacturing, Clinical, and Commercial teams to obtain documentation required for regulatory submissions.
• Maintain regulatory records and ensure timely renewals of licenses, registrations, and certifications.
• Provide regulatory guidance during product development and lifecycle management.

Required Skills

• Strong understanding of global regulatory frameworks and submission processes.
• Knowledge of FDA, EMA, CDSCO, ICH, WHO, ISO, GMP, GLP, and GCP guidelines.
• Experience in preparing CTD/eCTD dossiers.
• Familiarity with regulatory requirements for pharmaceuticals, biologics, diagnostics, or medical devices.
• Excellent scientific writing, documentation, and technical review skills.
• Strong analytical, organizational, and problem-solving abilities.
• Ability to manage multiple projects and meet strict deadlines.

Qualification:

• Ph.D. in Life Sciences, Pharmacy, Pharmaceutical Sciences, Molecular Biology, Biochemistry, Microbiology and Biomedical Sciences.
• Regulatory Affairs certification (RAC) will be an added advantage.