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

med-in.at

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 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 pharmaceutical experience
  • Expertise in combination product regulatory development
  • Strong knowledge of design controls process
  • Experience with IND/CTA/NDA/MAA submissions
  • Ability to review scientific information critically

Nice-to-have

  • Passion for continuous learning and self-development
  • Superb collaboration and cross-functional communication skills
  • Rapid disciplined decision making under pressure
  • Innovative problem-solving approaches for complex issues
  • Understanding of chemical and pharmaceutical operations

Key Requirements

  • Bachelor's degree in biological science or engineering (Master's preferred)
  • Minimum 10 years relevant experience in regulatory CMC or manufacturing
  • Subject matter expertise in combination product regulatory development
  • Experience with IDE/IND/510(k) clearances and CE mark authorizations
  • US residency required (No VISA sponsorship available)

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter