Manager - Regulatory Affairs

Abbott

Mumbai, India
Not specified; base pyy n/a; pyy range may vary by...
10 years regulatory affairs experience
Product registration and submission management
Cmc regulatory knowledge and strategy
The role involves actively leading product registrations by preparing documentation for complex filings and managing project timelines

Job Summary

  • The role involves actively leading product registrations by preparing documentation for complex filings and managing project timelines.
  • Candidates must develop regulatory CMC strategies, identify risks, and ensure products remain compliant with global and regional legislation.
  • This position requires representing the Regulatory CMC function in project meetings and maintaining strong relationships with affiliate colleagues.

Matching Summary

The role involves actively leading product registrations by preparing documentation for complex filings and managing project timelines.

Salary

Not specified; Base pay N/A; Pay range may vary by location

Skills & Requirements

Must-have

  • 10 years Regulatory Affairs experience
  • Product registration and submission management
  • CMC regulatory knowledge and strategy
  • Health agency interaction and liaison
  • Cross-functional team collaboration

Nice-to-have

  • Project management skills for complex filings
  • Process improvement and innovation mindset
  • Mentoring junior team members
  • Ability to challenge peers constructively
  • Strong adaptability to changing priorities

Key Requirements

  • Bachelor's Degree in pharmacy, biology, chemistry, or related field
  • Minimum 10 years of experience in Regulatory Affairs, R&D, or Manufacturing
  • Specialist regulatory knowledge of assigned country or product-class requirements

Work Rights

Not specified

Tailored Resume

Cover Letter