Job Title: Regulatory Affairs Executive / Officer
Location: Ambattur, Chennai
Experience: 2 – 5 Years
Industry: Medical Devices / Pharmaceuticals / Healthcare Manufacturing
Contact: 9489916654
Job Summary:
We are looking for a detail-oriented Regulatory Affairs professional to manage product registrations, licensing, and compliance documentation, ensuring all company products meet applicable regulatory standards and are approved for manufacture, sale, and distribution.
Key Responsibilities:
- Prepare, review, and submit regulatory documents/dossiers for product registration and licensing (CDSCO, State FDA, BIS, ISO, CE, etc. as applicable)
- Ensure compliance with regulatory requirements for medical devices/pharma products across domestic and export markets
- Liaise with regulatory authorities, testing labs, and certification bodies for approvals and renewals
- Maintain and update regulatory files, licenses, and product technical documentation
- Coordinate with QA/QC, R&D, and production teams to ensure regulatory compliance during product development and post-market changes
- Track changes in regulatory guidelines and ensure timely implementation
- Support internal and external audits (ISO 13485, CDSCO, WHO-GMP, etc.)
- Manage product labeling, artwork, and instructions for use (IFU) as per regulatory norms
- Maintain regulatory compliance calendar for renewals, license validity, and submissions
Required Skills & Qualifications:
- Bachelor's/Master's degree in Pharmacy, Life Sciences, Biotechnology, or related field
- 2–5 years of relevant experience in Regulatory Affairs, preferably in medical devices or pharmaceutical manufacturing
- Working knowledge of CDSCO, Medical Device Rules (MDR) 2017, ISO 13485, CE marking, and related regulatory frameworks
- Strong documentation and drafting skills
- Good communication and coordination skills to liaise with authorities and internal teams
- Proficiency in MS Office and regulatory submission portals
Preferred:
- Prior experience with CDSCO/State licensing processes
- Experience handling audits or certifications (ISO, WHO-GMP)
Contact: 9489916654
Pay: From ₹30,000.00 per month
Benefits:
- Cell phone reimbursement
- Flexible schedule
- Paid sick time
Work Location: In person
