Associate Director, Global Regulatory CMC

Overview The Associate Director, Global Regulatory, CMC will coordinate regulatory CMC activities for one or more products through all stages of a product lifecycle. The role involves developing global regulatory CMC strategies and guiding product teams, with responsibility for preparing CMC and quality-related agency correspondence and regulatory applications. The individual will manage multiple projects in a fast, results-oriented environment to support the development of transformative medicines. 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 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 and advise Manufacturing, Quality and Process/Analytical Development groups regarding applicability and impact on internal programs. Qualifications BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field. 8+ years of experience in the pharmaceutical/biotech industry with a 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 regulatory procedures and legislation related to CMC for drug development, product registration, line extension and license maintenance. Ability to collaborate effectively in a dynamic, cross-functional matrix environment to drive critical regulatory milestones. Ability to work independently. Exceptional written and oral communication skills. Compensation and Benefits The salary range for this role is $142,500.00 - $256,500.00. This reflects the range Moderna believes it would pay for this role at the time of posting. An individual’s position within the range will be based on competencies, education, qualifications, certifications, experience, skills, performance, and business needs. The successful candidate may be eligible for an annual discretionary bonus, other incentives, or equity, subject to company criteria. Equal Opportunity Moderna is an equal employment opportunity and non-discrimination employer. We consider qualified applicants regardless of 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 characteristic protected by law. Moderna is an E-Verify Employer in the United States. We may provide accommodations for applicants with disabilities upon request at View email address on click.appcast.io. #J-18808-Ljbffr Moderna Therapeutics