Manager Regulatory Affairs, Cmc Biosimilar

Abbott

Mumbai, India
Not specified; base pyy n/a; range may vary by loc...
10 years biosimilar regulatory experience
Us and eu regulatory environment exposure
Product registration and submission management
The role involves actively leading product registrations by preparing documentation for complex biosimilar filings

Job Summary

  • The role involves actively leading product registrations by preparing documentation for complex biosimilar filings.
  • Candidates must develop Regulatory CMC strategies to identify, communicate, and mitigate risks for assigned products.
  • The position requires representing the Regulatory CMC function at project meetings and maintaining strong relationships with affiliate colleagues.

Matching Summary

The role involves actively leading product registrations by preparing documentation for complex biosimilar filings.

Salary

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

Skills & Requirements

Must-have

  • 10 years biosimilar regulatory experience
  • US and EU regulatory environment exposure
  • Product registration and submission management
  • CMC strategy development and risk mitigation
  • Health agency interaction and deficiency responses

Nice-to-have

  • Experience in emerging markets or rest of world
  • Project management skills for complex filings
  • Cross-functional team leadership and collaboration
  • Process improvement and innovation mindset
  • Mentoring junior team members

Key Requirements

  • Minimum 10 years of experience in Biosimilar Global Regulatory Affairs
  • Proven exposure to US and EU regulatory environments
  • General knowledge of global and regional regulatory requirements

Work Rights

Not specified

Tailored Resume

Cover Letter