Associate Principal Scientist, Regulatory Affairs-cmc

29

Base: $142,400.00 - $224,100.00; bonus/equity: ann...
Hybrid (3 days on-site, 1 day remote)
5+ years regulatory cmc experience
Preparation of ind nda maa filings
Global regulatory strategy development
This job posting is for an Associate Principal Scientist in Regulatory Affairs-CMC at a pharmaceutical company, requiring a strong background in regulatory strategies for CMC submissions. The role emphasizes collaboration, adaptability, and effective communication to ensure compliance with global regulations for pharmaceutical products

Job Summary

  • The role is responsible for developing and implementing CMC regulatory strategies for the company's 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 while ensuring robust assessment of global requirements.
  • The position offers a competitive salary range of $142,400.00 - $224,100.00 along with comprehensive benefits including medical, dental, vision, and 401(k) retirement plans.

Matching Summary

Match Score: 85

This job posting is for an Associate Principal Scientist in Regulatory Affairs-CMC at a pharmaceutical company, requiring a strong background in regulatory strategies for CMC submissions. The role emphasizes collaboration, adaptability, and effective communication to ensure compliance with global regulations for pharmaceutical products.

Salary

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

Skills & Requirements

Must-have

  • 5+ years regulatory CMC experience
  • Preparation of IND NDA MAA filings
  • Global regulatory strategy development
  • Biological science or engineering degree
  • Proficiency in English communication

Nice-to-have

  • Experience with in-license due diligence
  • Innovative problem-solving approaches
  • Ability to work under pressure
  • Superb collaboration skills
  • Additional language skills

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

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