Associate Director, Global Regulatory, CMC

Associate Director, Global Regulatory-CMC The Associate Director, Global Regulatory-CMC will coordinate regulatory CMC activities for one or more products across their lifecycle, develop global regulatory CMC strategies, collaborate with stakeholders to execute strategies in alignment with business priorities, provide guidance to product teams, prepare agency correspondence and regulatory applications, and manage multiple projects in a fast, results-oriented environment to bring transformative medicines to patients. Responsibilities Develop/implement effective CMC regulatory strategies for global submissions (e.g. "IND/CTA/BLA/MAA") and identify regulatory risks Provide guidance for regulatory CMC aspects of product development projects Review documents for submission‑readiness to ensure all submissions conform to health authority guidelines Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions Perform assessment of manufacturing change controls Support development of regulatory processes and procedures to support CMC components of regulatory submissions Support the creation and maintenance of CMC submission templates Provide CMC regulatory guidance to manufacturing and quality teams; evaluate CMC change controls Provide interpretation of regulatory guidance documents, regulations and directives – advise Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs Basic Qualifications BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required 8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus 5+ years of experience in Biologics focused Regulatory CMC Strong knowledge of current Global CMC regulations, including CTD format and content of CMC regulatory submissions Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance Preferred Qualifications Ability to effectively collaborate in a dynamic, cross‑functional matrix environment to drive meeting each program’s critical regulatory milestones Ability to work independently Exceptional written and oral communication A desire to make an impact as part of a high‑growth, transformational company that is Bold, Relentless, Curious, and Collaborative Pay & Benefits 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 The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. 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). As such, employment is contingent upon the applicant’s ability to access export‑controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non‑U.S. persons to apply for an export control license. Moderna is committed to equal employment opportunity and non‑discrimination for all employees and qualified applicants without regard to a person's 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 a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations: We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 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. #J-18808-Ljbffr BioSpace