Senior Regulatory Affairs Program Lead (apac) - Abiomed, Inc.

Johnson & Johnson Innovative Medicine

Danvers, Massachusetts, United States of America
Base: $109,000.00 - $174,800.00; bonus/equity: not...
Hybrid
Regulatory dossier/sted/database management
Health authority inquiry response
Product development regulatory input
This role will work closely with in-country Regulatory Affairs representatives in the Asia Pacific to ensure efficient regulatory submission

Job Summary

  • This role will work closely with in-country Regulatory Affairs representatives in the Asia Pacific to ensure efficient regulatory submission.
  • You will be responsible for creating, maintaining, and updating relevant regulatory dossiers for product registrations, change notifications, or annual reports for Asia Pacific Regions.
  • The anticipated base pay range for this position is $109,000.00 - $174,800.00.

Matching Summary

This role will work closely with in-country Regulatory Affairs representatives in the Asia Pacific to ensure efficient regulatory submission.

Salary

Base: $109,000.00 - $174,800.00; Bonus/Equity: Not specified; Benefits: Vacation, Sick time, Holiday pay, Work/Personal/Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, Military Spouse Time-Off

Skills & Requirements

Must-have

  • Regulatory dossier/STED/database management
  • Health Authority inquiry response
  • Product development regulatory input
  • Manufacturing process change review
  • Regulatory landscape monitoring

Nice-to-have

  • Cross-functional collaboration with R&D
  • Scientific and regulatory writing
  • Fluent in Asian languages

Key Requirements

  • Bachelor’s Degree required
  • 6+ years Regulatory Affairs experience
  • Medical Device experience preferred
  • Class III Medical Device submission experience
  • Asia and Middle East submission experience

Work Rights

Not specified

Tailored Resume

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