Nysa Biomed Pvt. Ltd. is looking for an experienced Regulatory Affairs Executive to manage product registration, regulatory documentation, and compliance activities. The candidate will be responsible for coordinating with regulatory authorities, preparing dossiers, and ensuring compliance with applicable pharmaceutical regulations.
Key Responsibilities
- Prepare, review, and compile regulatory dossiers for product registration and renewals.
- Handle product registration, license applications, and regulatory submissions for domestic and export markets.
- Coordinate with CDSCO, State FDA, and other regulatory authorities.
- Prepare and review technical documents, declarations, and regulatory responses.
- Maintain regulatory records, licenses, and product documentation.
- Coordinate with QA, QC, Production, R&D, Packaging Development, and Pharmacovigilance teams for regulatory requirements.
- Track regulatory changes and ensure timely implementation.
- Support new product registrations, variations, amendments, and renewals.
- Respond to regulatory queries within the specified timelines.
- Participate in internal and external audits and regulatory inspections.
- Ensure compliance with applicable pharmaceutical regulations and company SOPs.
Eligibility
- Qualification: B.Pharm / M.Pharm
- Experience: 3–5 years in Regulatory Affairs (Pharmaceutical Industry)
Required Skills
- Strong knowledge of pharmaceutical regulatory requirements.
- Experience in dossier preparation and regulatory submissions.
- Knowledge of CDSCO, State FDA, and export registration processes.
- Good documentation and technical writing skills.
- Proficiency in MS Office.
- Strong communication, coordination, and analytical skills.
- Ability to manage multiple regulatory projects and meet deadlines.
Pay: ₹12,367.87 - ₹32,531.96 per month
Benefits:
- Paid time off
- Provident Fund
Work Location: In person
