Associate Principal Scientist, Regulatory Affairs-cmc

539

Base: $142,400.00 - $224,100.00; bonus/equity: ann...
Hybrid
5+ years regulatory cmc experience
Preparation of nda/maa submissions
Development of global regulatory strategy
The company is seeking an Associate Principal Scientist in Regulatory Affairs-CMC to develop and implement regulatory strategies for pharmaceutical products, ensuring compliance with global regulations. The ideal candidate should have at least five years of relevant experience, strong leadership skills, and a background in biological sciences or engineering

Job Summary

  • The role is responsible for developing and implementing CMC regulatory strategies for pharmaceutical pipeline products in accordance with global regulations.
  • Candidates must lead the preparation and submission of CMC dossiers including IND, CTA, original NDA, and MAA documents.
  • The position offers a comprehensive benefits package including medical, dental, vision, 401(k), and paid holidays.

Matching Summary

Match Score: 85

The company is seeking an Associate Principal Scientist in Regulatory Affairs-CMC to develop and implement regulatory strategies for pharmaceutical products, ensuring compliance with global regulations. The ideal candidate should have at least five years of relevant experience, strong leadership skills, and a background in biological sciences or engineering.

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid time off

Skills & Requirements

Must-have

  • 5+ years regulatory CMC experience
  • Preparation of NDA/MAA submissions
  • Development of global regulatory strategy
  • Proficiency in English communication

Nice-to-have

  • Biologics License Application (BLA) experience
  • Cross-cultural awareness and collaboration
  • Experience with in-license due diligence
  • Innovative problem-solving capabilities

Key Requirements

  • Bachelor's degree in biological science or engineering
  • At least five years of relevant CMC experience
  • Advanced degree preferred
  • No visa sponsorship available

Work Rights

Not specified

Tailored Resume

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