About the job
We are excited to announce immediate openings for the position of “Regulatory Affairs Manager” with one of our esteemed clients located in Hosur.
About the Position:
Title: Regulatory Affairs Manager
Qualifications: B. Sc / M. Sc
Experience: 8 - 10 years in Bulk Drugs / API
Location: Hosur
Key Responsibilities:
- Prepare and review Drug Master Files and Common Technical Documents for various drug substances.
- Compile and submit Technical Packages and Product Dossiers.
- Draft Declarations of Access, Letters of Access, Letters of Commitment, and Submission Letters.
- Address deficiencies raised by regulatory agencies and customers.
- Prepare and submit Quality Questionnaires and related documentation from customers.
- Collaborate with Quality Control, Quality Assurance, Stores, Production, and R&D regarding regulatory requirements.
- Provide marketing support as needed.
- Prepare and submit documents for Drug Licenses, Written Confirmations, NOCs, FSSAI Licenses, Free Sale Certificates, and GMP Certificates.
- Undertake any other tasks assigned by the department head.
- Enhance, periodically review, and update current SOPs and work systems.
- Ensure that sourcing materials, manufacturing, and testing are aligned with the dossier accepted by the relevant regulatory agency.
- Monitor the qualification of new or modified areas/equipment and ensure their requalification.
- Review technical and quality agreements.

