Director, Global Regulatory Science CMC, Respiratory Products - BioSpace : Job Details

Job Details The Role: The Director, Global Regulatory Science CMC will be responsible for leading regulatory CMC activities for one or more products, depending on complexity, through all stages of a product's lifecycle.The Director will manage a small group of individuals responsible for developingglobal regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities.The Director will be expected to provide guidance to the product teams supporting products in their portfolio. In addition, the individual will be responsible for preparation, review, and approval of CMC and Quality related Health Authority correspondence and regulatory applications.The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on bringing a new generation of transformative medicines for patients. Effective communication skills will be critical to overall success. The individual will also be expected to mentor and develop their direct reports. The Director, Global Regulatory Science CMC can be based either at the Norwood, MA or Basel, Switzerland site. Here's What You'll Do:

• Develop/implement effective CMC regulatory strategies for 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 that all submissions conform to Health Authority guidelines
• Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
• Develop 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 manufacturingand quality teams; evaluate CMC change controls
• Perform assessment of manufacturing 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
• Lead oversight of multiple programs in Respiratory franchise

Here's What You'll Need:

• Bachelor's degree in a scientific/engineering discipline
• 12+ years of experience in the pharmaceutical/biotech industry
• 8 + years of experience in Regulatory CMC
• Strong knowledge of current Global CMC regulations, including with CTD format and content of CMC regulatory submissions
• Strong knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance
• Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones
• Prior management experience required
• Excellent interpersonal skills for internal and external negotiation and influence
• Exceptional written and oral communication skills

Here's What You'll Bring to the Table:

• Bachelor's degree with 15 years of experience in the pharmaceutical/biotech industry
• MS/PhD degree in Molecular Biology, Pharmaceutics, Chemistry, or closely related field is desirable
• 10+ years of experience in thepharmaceutical/biotechindustry, manufacturing and/or analytical focus
• 8+ years of experience in Biologics focused Regulatory CMC

At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities 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 [email protected] . 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. #LI-NH1 -