This role ensures obtaining regulatory approval for products and managing their life cycle with Indian Health Authority (CDSCO) and NMRA Sri Lanka
Job Summary
This role ensures obtaining regulatory approval for products and managing their life cycle with Indian Health Authority (CDSCO) and NMRA Sri Lanka.
The manager will represent the company in discussions with CDSCO and government laboratories for registration sample testing and maintain a regulatory database.
Candidates must possess strong knowledge of Indian regulatory requirements and have a track record in managing product registrations and licenses.
Matching Summary
This role ensures obtaining regulatory approval for products and managing their life cycle with Indian Health Authority (CDSCO) and NMRA Sri Lanka.
Skills & Requirements
Must-have
Indian Health Authority CDSCO compliance
Product registration and life cycle management
NMRA Sri Lanka regulatory submissions
Veeva RA System expertise
Stakeholder management with government labs
Nice-to-have
Experience with biological products
Strong verbal and written communication skills
Creative problem solving abilities
Cross-functional collaboration experience
Project management capabilities
Key Requirements
Bachelor's degree in Pharmacy, Life Sciences, or Medicine
Minimum 5 years of pharmaceutical regulatory affairs experience
Expertise in Veeva RA System and Tool
Knowledge of Indian regulatory requirements interpretation