Director, Drug & Device Combo (Autoinjector/Inhalation) Reg.-CMC (Remote)
Merck
June 25, 2026
Remote
United States
Corporate Functions
Director/Principal Scientist, Devices and Drug-Device Combinations Regulatory CMC
Responsibilities
- Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery systems; assess scientific content and regulatory documentation to confirm acceptability and identify risks.
- Support drug-led CMC Product Team; deliver assigned regulatory activities.
- Lead technical content writing/review for combination product documentation (IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations, and responses to health authority questions).
- Identify, communicate, and escalate issues to Regulatory CMC Product Lead and Device Quality & Regulatory Affairs leadership.
- Ensure compliance-focused execution (training, efficiency, innovation, accuracy, safety); additional tasks as assigned.
Technical/Leadership Skills
- Review scientific information and evaluate whether arguments/data support conclusions.
- Strong oral/written communication; succinct, logical issue communication.
- Generate innovative solutions; collaborate with stakeholders/health authorities; adapt to changing priorities.
Education
- B.S. in biological science, engineering, or related field (advanced degree preferred). Pharmacy, Chemical/Biomedical Engineering, Biology, Microbiology, Biochemistry.
Required
- 10 years relevant experience (B.S./M.S.); minimum 5 years with Ph.D. in biological/pharmaceutical research, manufacturing/testing, or regulatory CMC.
Preferred
- Combination product regulatory development/manufacturing expertise; IDE/IND/510(k)/CE mark/NDA/BLA/post-approval experience; design controls knowledge; fields in Biology/Biochemistry/Chemistry/Engineering.
Skills (required)
- Adaptability, audit/compliance, change management, data integrity, leadership, life cycle support, regulatory CMC/communications/compliance/experience, technical writing.
- Preferred: drug product manufacturing, medical devices.
Benefits
- Annual bonus/long-term incentive (if applicable); medical/dental/vision and insurance for employee/family; retirement/401(k); paid holidays, vacation, compassionate and sick days.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Deadline is stated on the posting.
Responsibilities
- Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery systems; assess scientific content and regulatory documentation to confirm acceptability and identify risks.
- Support drug-led CMC Product Team; deliver assigned regulatory activities.
- Lead technical content writing/review for combination product documentation (IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations, and responses to health authority questions).
- Identify, communicate, and escalate issues to Regulatory CMC Product Lead and Device Quality & Regulatory Affairs leadership.
- Ensure compliance-focused execution (training, efficiency, innovation, accuracy, safety); additional tasks as assigned.
Technical/Leadership Skills
- Review scientific information and evaluate whether arguments/data support conclusions.
- Strong oral/written communication; succinct, logical issue communication.
- Generate innovative solutions; collaborate with stakeholders/health authorities; adapt to changing priorities.
Education
- B.S. in biological science, engineering, or related field (advanced degree preferred). Pharmacy, Chemical/Biomedical Engineering, Biology, Microbiology, Biochemistry.
Required
- 10 years relevant experience (B.S./M.S.); minimum 5 years with Ph.D. in biological/pharmaceutical research, manufacturing/testing, or regulatory CMC.
Preferred
- Combination product regulatory development/manufacturing expertise; IDE/IND/510(k)/CE mark/NDA/BLA/post-approval experience; design controls knowledge; fields in Biology/Biochemistry/Chemistry/Engineering.
Skills (required)
- Adaptability, audit/compliance, change management, data integrity, leadership, life cycle support, regulatory CMC/communications/compliance/experience, technical writing.
- Preferred: drug product manufacturing, medical devices.
Benefits
- Annual bonus/long-term incentive (if applicable); medical/dental/vision and insurance for employee/family; retirement/401(k); paid holidays, vacation, compassionate and sick days.
Application
- Apply via https://jobs.merck.com/us/en (or Workday Jobs Hub for current employees). Deadline is stated on the posting.