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 pharmaceutical experience
Expertise in combination product regulatory development
Experience with ide/ind/510(k)/nda/bla submissions
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 experience reviewing detailed scientific information to assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
  • The position offers a comprehensive benefits package including medical, dental, vision, retirement benefits like 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 pharmaceutical experience
  • Expertise in combination product regulatory development
  • Experience with IDE/IND/510(k)/NDA/BLA submissions
  • 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
  • Excellent cross-cultural awareness skills
  • Proactive problem solving approach
  • Superb collaboration and interpersonal skills

Key Requirements

  • Bachelor's degree required; advanced degree preferred
  • Minimum 10 years relevant experience (or 5 with PhD)
  • Subject matter expertise in combination product regulatory development
  • No visa sponsorship available

Work Rights

Not specified

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