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

Merck & Co., Inc.

Base: $190,800.00 - $300,300.00; bonus/equity: ann...
Hybrid
10 years relevant pharmaceutical experience
Expertise in combination product regulatory development
Strong knowledge of design controls process
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 possess a demonstrated background in reviewing scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
  • The position offers a competitive salary range of $190,800.00 to $300,300.00 along with comprehensive benefits including medical, dental, vision, and retirement plans.

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
  • Strong knowledge of design controls process
  • Experience with IND/510(k)/NDA submissions
  • Ability to review scientific data and arguments

Nice-to-have

  • Passion for continuous learning and self-development
  • Innovative problem-solving approaches
  • Rapid disciplined decision making capabilities
  • Superb collaboration and interpersonal skills
  • Experience with medical device manufacturing

Key Requirements

  • Bachelor's degree required; advanced degree preferred
  • Minimum 10 years relevant experience for Bachelor/Master holders
  • Minimum 5 years relevant experience for PhD holders
  • Subject matter expertise in combination product regulatory development
  • US work authorization required (No visa sponsorship)

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter