Senior Specialist - Regulatory Affairs

Job Description:

Responsibilities

• Responsible for Medical Device and Drug registration in CDSCO, State FDA office and other government office.
• Liaising with key health authority agencies during development, registration, and product lifecycle activities to resolve regulatory issues and/or negotiate approvals.
• Execution of Regulatory Submission plan. Manage Regulatory Information Management System (RIMS) to ensure all product information for medical devices and drugs is contemporaneous, accurate, and compliant to support uninterrupted market supply.
• Maintain up-to-date local registration dossiers, technical files, regulatory resources, and applicable legislation for both drugs and medical devices for India market.
• Provide regular updates in the Global Regulatory Roadmap and RIMS on the registration status of all products, including updates to the local country Roadmap.
• Implementation of Quality Management System (QMS) as part of a broader regional quality initiative.
• Ensure all labelling/ redressing activities are conducted in full compliance with Good Manufacturing Practice (GMP) requirements.
• Responsible for MRP implementation and NPPA compliance.

Qualification & Experience

•  Education and qualifications required or expected
• Degree in Pharmacy, Chemical, Bioengineering, Health Professional.
• Desirable master’s degree in quality, regulatory, science or pharmacy
•  Professional Experience (in years):
• At least 5 years of Industrial experience in Medical Device or healthcare Industry and strong engagement HAs.