Director, Drug & Device Combo (Autoinjector/Inhalation) Reg.-CMC (Remote)
Not Disclosed•Full-TimeOn-site
location_onVermont State Office Building, 118-120;120, State Street, Montpelier, Washington County, Vermont, 05602, United States
As a Director/Principal Scientist in Devices and Drug-Device Combinations CMC, you will serve as a strategic technical partner within the Autoinjector Development Programs. Reporting to the Director of Device Regulatory Affairs, your mission is to ensure the successful regulatory approval and market maintenance of our company's autoinjector, inhalation, and other delivery system products globally.
This role sits at the critical intersection of drug and device development. You will support the drug-led CMC Product Team across the entire product lifecycle, from development through to marketed phases, covering small molecules, biologics, and vaccines. Your work ensures that technical content is robust, scientifically sound, and compliant with global regulations, directly influencing the speed and success of product launches.
Your day involves leading the regulatory strategy for complex combination products. You will critically evaluate scientific documentation for IND/CTA, NDA/MAA, and post-approval submissions, ensuring that technical arguments are clearly presented and adequately supported by data. You will act as a bridge between cross-functional partners, health authorities, and leadership, identifying potential risks early and communicating them succinctly. Whether drafting agency background packages or responding to complex health authority questions, you will apply your expertise to drive innovation and compliance in a fast-paced environment.
We are committed to a fair and efficient hiring process that allows candidates to demonstrate their true capabilities.
Merck embraces the value of bringing together talented, committed people with diverse experiences, perspectives, skills, and backgrounds. We believe that the fastest way to breakthrough innovation is when people with diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment. We 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. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.
We also adhere to local fair chance laws, including the San Francisco Fair Chance Ordinance and the Los Angeles Fair Chance Initiative for Hiring Ordinance, ensuring qualified applicants with arrest and conviction records are considered for employment in compliance with applicable regulations.
Work model: On-site
Vermont State Office Building, 118-120;120, State Street, Montpelier, Washington County, Vermont, 05602, United States
Montpelier, Vermont
Advanced degree (Master's or Ph.D.). Subject matter expertise in combination product regulatory development and manufacturing. Experience with IDE/IND/510(k) clearances/CE mark authorizations/NDA/BLA/post-approval experience in medical devices or combination products. Strong knowledge and understanding of design controls process. Preferred fields of study include Biology, Biochemistry, Chemistry, or Engineering. Skills in Drug Product Manufacturing and Medical Devices.
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Skills: Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Technical Writing, Pharmaceutical Process Development, Drug Product Manufacturing, Medical Devices, Design Controls Process, Audits Compliance.
Education: B.S. in biological science, engineering, or related field required; Advanced degree (Master's) preferred; Ph.D. degree preferred (reduces experience requirement).