Executive Director, CMC Regulatory Science

Role The individual in this position will be based at the Norwood MA site and will be responsible for managing a team of CMC experts that prepare and oversee CMC and Quality related agency correspondence and regulatory applications. This position will oversee the product strategy for all the products in their portfolio and lead and support all regulatory activities to provide high quality CMC sections of regulatory documentation. Additionally, interfacing with the leadership in our departments and assuring clear communication of regulatory topics is critical. Reg CMC strategy development to align with the needs of the company, the regulators and the patients will be a key component. Responsibilities Lead a team to develop/implement effective CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks Provide expertise for regulatory CMC aspects of product development projects Review documents for submission‑readiness, to ensure that all submissions conform to health authority guidelines and meet the needs of the company Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions at the expert level Develop regulatory processes and procedures to support CMC components of regulatory submissions Support the creation and maintenance of CMC submission templates Provide CMC regulatory expertise to manufacturing and quality teams; evaluate CMC change controls Provide interpretation of domestic and international regulatory guidance documents, regulations and directives – advise Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs Be a site expert Lead oversight of multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases) and drive Reg CMC strategy successfully Basic Qualifications MS/PhD degree in a scientific/engineering discipline 10+ years of experience in the pharmaceutical/biotech industry 8+ years of experience in Regulatory CMC, including DMF/ASMF submissions Strong knowledge of current US, EU, and ROW regulations Strong experience with CTD format and content regulatory filings Exceptional written and oral communication Preferred Qualifications MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable 10+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus 8+ years of experience in Biologics focused Regulatory CMC Pay & Benefits The salary range for this role is $224,900.00 - $404,600.00. Best‑in‑class healthcare coverage, plus voluntary benefit programs to support your unique needs A holistic approach to well‑being, with access to fitness, mindfulness, and mental health support Family planning benefits, including fertility, adoption, and surrogacy support Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown Savings and investment opportunities to help you plan for the future Location‑specific perks and extras Equal Opportunity Moderna is an equal employment opportunity employer. We are committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E‑Verify Employer in the United States. Accommodations Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at View email address on click.appcast.io. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). Employment is contingent upon the applicant’s ability to access export‑controlled information in accordance with U.S. law. Only U.S. persons (U.S. citizens, lawful permanent residents, asylees, or refugees) are currently eligible to access such information without an export license. Candidates who do not meet these criteria may still be considered, contingent on the company’s ability to obtain any required export control license. #J-18808-Ljbffr