Director, Drug & Device Combo – Autoinjector, Inhalation Reg.-CMC

MSD

Director/Principal Scientist leading Device Regulatory Affairs for drug-device combinations. Overseeing CMC regulatory activities and ensuring compliance in product development and market supply.

Posted 5/17/2026full-timeRemote • New Jersey • 🇺🇸 United StatesLead💰 $190,800 - $300,300 per yearWebsite

About the role

Key responsibilities & impact

Lead Device Regulatory Affairs strategies for autoinjector, inhalation, and other delivery system development programs by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks.
Support the drug-led CMC Product Team on assigned products and be accountable for the delivery of all assigned regulatory activities.
Lead technical content writing and review in autoinjector (other device)/integral combination product documentation including IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations and responses to health authority questions per established business processes and systems.
Identify, communicate, and escalate potential issues to Regulatory CMC Product Lead and Device Quality & Regulatory Affairs Leadership
Apply an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our human medicinal products worldwide.
Conduct all activities with an unwavering focus on compliance, including staying current on all training.
Carry out all assignments to the standards of efficiency, innovation, accuracy, and safety in accordance with company and regulatory requirements.

Requirements

What you’ll need

B.S. in a biological science, engineering, or a related field (advanced degree preferred)
10 years relevant experience including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields for candidates with a Bachelor’s degree, or Master’s degree; minimum 5 years for candidates with a Ph.D. degree
adaptability
audits compliance
change management
confidentiality
cross-cultural awareness
data integrity
decision making
employee training programs
leadership
life cycle support
pharmaceutical process development
regulatory CMC
regulatory communications
regulatory compliance
regulatory experience
technical writing

Benefits

Comp & perks

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays, vacation, and compassionate and sick days

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

technical writingregulatory CMCpharmaceutical process developmentregulatory complianceregulatory communicationsbiological researchpharmaceutical researchmanufacturingtestinglife cycle support

Soft Skills

adaptabilityaudits compliancechange managementconfidentialitycross-cultural awarenessdata integritydecision makingemployee training programsleadership

Certifications

B.S. in biological scienceB.S. in engineeringadvanced degree preferred