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

Merck is hiring a Director of Regulatory CMC Affairs for Drug-Device Combination Products (Autoinjector and Inhalation Systems). This is a full-time, remote position based in Salem, Marion County, supporting our next-generation combination delivery systems.

About the Role

As Director of Regulatory CMC for Drug-Device Combination Products, you will lead Chemistry, Manufacturing, and Controls regulatory strategy and execution for autoinjector and inhalation delivery systems. Working within the Device Regulatory Affairs organization, you'll drive CMC regulatory submissions, ensure compliance with FDA expectations, and support cross-functional teams bringing innovative combination products to market.

What You'll Do

• Direct CMC regulatory activities and strategy for drug-device combination products, including autoinjector and inhalation delivery platforms
• Develop and submit regulatory CMC documentation for IND, BLA, and NDA filings aligned with FDA guidance on combination products
• Partner with Chemistry, Manufacturing, Quality, and Clinical teams to ensure CMC readiness across development stages
• Lead regulatory responses to FDA questions and inspections related to device and combination product manufacturing
• Establish CMC strategies for novel delivery technologies and manufacturing processes
• Maintain compliance with applicable regulations and leverage evolving FDA regulatory frameworks
• Mentor and provide direction to CMC regulatory professionals

What We're Looking For

• Advanced degree (MS or PhD) in Chemistry, Pharmaceutics, Chemical Engineering, or related field
• 10+ years of pharmaceutical or device regulatory affairs experience, with direct CMC expertise
• Demonstrated experience with drug-device combination products and delivery system regulation
• Strong knowledge of FDA guidance documents and CMC submission requirements
• Experience leading regulatory teams and cross-functional initiatives
• Excellent written and verbal communication skills
• Self-directed problem-solver with strong project management abilities

About Merck

Merck invests in breakthrough research and development to bring therapies and vaccines to patients worldwide. We're committed to innovation across therapeutic areas, including advancing combination products that improve patient outcomes.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.