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

About the Role

Reporting to the Director of Device Regulatory Affairs for Autoinjector Development Programs, the Director/Principal Scientist serves as a strategic technical leader for our Devices and Drug-Device Combinations CMC function. This role is pivotal in supporting the regulatory activities for our autoinjector, inhalation, and other delivery system products, ensuring alignment with global regulations and guidelines.

You will act as the bridge between complex scientific data and regulatory strategy, providing critical technical content input and coordinating CMC submissions for assigned activities. Whether supporting small molecules, biologics, or vaccines in development or marketed phases, you will lead the assessment of scientific content and the critical evaluation of regulatory documentation to confirm acceptability and identify potential risks. Your work ensures the approval, launch, and maintenance of market supply for our human medicinal products worldwide.

Day in the Life

Your day involves leading technical content writing and review for autoinjector and integral combination product documentation, including IND/CTA, NDA/MAA, agency background packages, and post-approval submissions. You will partner with drug-led CMC Product Teams, cross-functional partners, and health authorities to navigate complex regulatory landscapes. A key part of your mission is to identify, communicate, and escalate potential issues while applying innovative solutions to complex regulatory problems. You will maintain an unwavering focus on compliance, ensuring all assignments meet the highest standards of efficiency, innovation, accuracy, and safety.

Hiring Process & Application

Current employees should apply via the Workday Jobs Hub. Current contingent workers and external candidates should apply through the Merck careers portal. If you require an accommodation during the application or hiring process, please utilize the dedicated survey link provided for US and Puerto Rico residents.

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We are committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

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