Manager / Senior Manager – Regulatory Affairs

AbbVie

Mumbai, India
Base: n/a; bonus/equity: not specified; benefits: ...
Regulatory pathway for new product introduction
Develop & implement regulatory strategies
Regulatory input to cmc data
Develop and implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and business needs

Job Summary

  • Develop and implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and business needs.
  • Responsible for end-to-end filing of New products to CDSCO and State FDA, well versed with filing applications on SUGAM portal.
  • Provide regulatory support for timely new product launches and manage submission dossiers with relevant regulatory authorities.

Matching Summary

Develop and implement regulatory strategies for new/generic product registrations in compliance with relevant regulations and business needs.

Salary

Base: N/A; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Regulatory pathway for New Product Introduction
  • Develop & implement regulatory strategies
  • Regulatory input to CMC data
  • End-to-end filing to CDSCO
  • Filing application on SUGAM portal
  • Address queries from CDSCO/State FDA
  • Subject expert committee (SEC) meetings

Nice-to-have

  • Collaborate with cross-functional teams
  • Deliver high quality dossiers
  • Timely new product launches
  • Identify new product opportunities

Key Requirements

  • 8-15 years experience
  • M. Pharm/B. Pharm
  • FSSAI experience desirable

Work Rights

Not specified

Tailored Resume

Cover Letter