Director, Drug & Device Combo (Autoinjector/Inhalation) Reg.-CMC (Remote)

Merck is seeking a Director, Drug & Device Combo (Autoinjector/Inhalation) Reg.-CMC to lead regulatory chemistry, manufacturing, and controls activities for its autoinjector and inhalation delivery programs in a fully remote capacity. Based remotely, you will partner with cross‑functional teams to ensure that device‑combined products meet global CMC standards from early development through commercial launch.

About the Role

In this leadership position you will oversee the CMC regulatory strategy for combination products, guiding teams through the preparation of technical sections for INDs, NDAs, BLAs, and marketing authorizations worldwide. You will serve as the primary regulatory CMC contact for autoinjector and inhalation projects, ensuring alignment with device development timelines and quality expectations.

What You'll Do

• Develop and execute CMC regulatory plans for autoinjector, inhalation, and other drug‑device combination products
• Author and review CMC modules of regulatory submissions, including comparability protocols, stability data, and manufacturing process descriptions
• Partner with device engineering, formulation, quality, and clinical teams to gather CMC information and resolve open issues
• Maintain awareness of evolving FDA, EMA, and other health‑authority guidance on combination product CMC requirements
• Provide regulatory CMC oversight during technology transfer, scale‑up, and lifecycle management activities
• Mentor junior regulatory scientists and contribute to functional best practices and training initiatives

What We're Looking For

• Advanced degree (PhD preferred) in pharmaceutical sciences, engineering, chemistry, or a related discipline
• Substantial experience in CMC regulatory affairs for drug‑device combination products, particularly autoinjectors or inhalation systems
• Proven track record of preparing and defending CMC sections of global regulatory submissions
• Strong understanding of device design controls, materials, sterilization, and manufacturing processes as they relate to CMC
• Excellent communication skills with the ability to influence cross‑functional stakeholders in a matrix environment
• Familiarity with ICH Q8‑Q11, QbD principles, and FDA’s combination product jurisdiction policies
• Demonstrated leadership ability, including mentoring and project management experience

About Merck

Merck is a global healthcare leader dedicated to improving health and well‑being through innovative medicines, vaccines, and biologics. The company fosters a culture of scientific excellence, collaboration, and integrity, empowering employees to make a meaningful impact on patients worldwide.

How to Apply

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