Manager, Regulatory Affairs

Takeda UK

Gurgaon, India
Indian health authority cdsco compliance
Nmra sri lanka regulatory submissions
Product registration and life cycle management
This role ensures obtaining regulatory approval for products and managing their life cycle with Indian and Sri Lankan health authorities

Job Summary

  • This role ensures obtaining regulatory approval for products and managing their life cycle with Indian and Sri Lankan health authorities.
  • The incumbent will manage complex regulatory submissions including Marketing Authorizations, variations, and label updates through distributors.
  • The position requires representing the company in consultations with CDSCO, NIB, IPC, and State FDA for registration sample testing.

Matching Summary

This role ensures obtaining regulatory approval for products and managing their life cycle with Indian and Sri Lankan health authorities.

Skills & Requirements

Must-have

  • Indian Health Authority CDSCO compliance
  • NMRA Sri Lanka regulatory submissions
  • Product registration and life cycle management
  • Marketing Authorization and Import License
  • Stakeholder management with government bodies

Nice-to-have

  • Experience with biological products
  • Veeva RA System expertise
  • Cross-functional collaboration skills
  • Creative problem solving abilities

Key Requirements

  • Bachelor's degree in Pharmacy or Life Sciences
  • Minimum 5 years pharmaceutical regulatory affairs experience
  • Strong knowledge of Indian regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter