Director, Drug & Device Combo (autoinjector/inhalation) Reg.-cmc (remote)

Merck & Co., Inc.

Remote, US
Base: $190,800.00 - $300,300.00; bonus/equity: ann...
Hybrid
10 years relevant regulatory cmc experience
Expertise in combination product regulatory development
Experience with ide/ind/510(k) clearances
The role involves leading device regulatory affairs strategies for autoinjector, inhalation, and other delivery system development programs while ensuring robust assessment of scientific content

Job Summary

  • The role involves leading device regulatory affairs strategies for autoinjector, inhalation, and other delivery system development programs while ensuring robust assessment of scientific content.
  • Candidates must have demonstrated ability to generate innovative solutions to complex regulatory problems and effectively communicate with key stakeholders and health authorities.
  • The position offers a comprehensive benefits package including medical, dental, vision, 401(k), and paid holidays with a salary range of $190,800.00 to $300,300.00.

Matching Summary

The role involves leading device regulatory affairs strategies for autoinjector, inhalation, and other delivery system development programs while ensuring robust assessment of scientific content.

Salary

Base: $190,800.00 - $300,300.00; Bonus/Equity: Annual bonus and long-term incentive eligible; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation

Skills & Requirements

Must-have

  • 10 years relevant regulatory CMC experience
  • Expertise in combination product regulatory development
  • Experience with IDE/IND/510(k) clearances
  • Strong knowledge of design controls process
  • Ability to review scientific information critically

Nice-to-have

  • Passion for continuous self-development
  • Rapid disciplined decision making capabilities
  • Superb collaboration skills under pressure
  • Innovative approaches to problem solving

Key Requirements

  • Bachelor's degree in biological science or engineering
  • Master's degree preferred
  • Ph.D. reduces experience requirement to 5 years
  • US residency required (no relocation)
  • No visa sponsorship available

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter