Associate Principal Scientist (assoc. Director), Regulatory Affairs - Cmc

Merck Sharp & Dohme Corp

Multiple Locations, US
Base: $142,400.00 - $224,100.00; bonus/equity: ann...
Hybrid (3 days on-site, 1 day remote)
Regulatory cmc experience with inhalation products
Preparation of regulatory filings (ind/nda/maa)
Experience with dry powder inhalers or metered dose inhalers
Merck Sharp & Dohme Corp is seeking an Associate Principal Scientist in Regulatory Affairs CMC to develop and implement regulatory strategies for small molecule respiratory and inhalation products. The ideal candidate should have extensive experience in regulatory CMC, particularly with inhalation products, and demonstrate strong technical leadership abilities

Job Summary

  • This role serves as a CMC Product Lead responsible for delivering all regulatory milestones for respiratory and inhalation product pipelines.
  • The successful candidate will lead the development of global regulatory strategies and manage the submission of complex CMC dossiers including IND, NDA, and MAA.
  • Employees are eligible for an annual bonus, long-term incentives, and a comprehensive benefits package including medical, dental, vision, and 401(k) retirement plans.

Matching Summary

Match Score: 85

Merck Sharp & Dohme Corp is seeking an Associate Principal Scientist in Regulatory Affairs CMC to develop and implement regulatory strategies for small molecule respiratory and inhalation products. The ideal candidate should have extensive experience in regulatory CMC, particularly with inhalation products, and demonstrate strong technical leadership abilities.

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

  • Regulatory CMC experience with inhalation products
  • Preparation of regulatory filings (IND/NDA/MAA)
  • Experience with dry powder inhalers or metered dose inhalers
  • Development of global regulatory strategies
  • Management of CMO/CRO partnerships

Nice-to-have

  • Innovative problem-solving approaches
  • Ability to work under pressure
  • Superb collaboration skills
  • Additional language skills beyond English
  • Familiarity with latest global regulatory guidance

Key Requirements

  • B.S. in biological science, engineering, or related field (advanced degree preferred)
  • At least five years of relevant experience in pharmaceutical research or regulatory CMC
  • Proficiency in English required

Work Rights

Not specified

Tailored Resume

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