Director, Global Regulatory Science CMC, Respiratory Products

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 products 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 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 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.

Heres What Youll 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

Heres What Youll Need:

• Bachelors 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 programs critical regulatory milestones

• Prior management experience required

• Excellent interpersonal skills for internal and external negotiation and influence

• Exceptional written and oral communication skills

Heres What Youll Bring to the Table:

• Bachelors 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. Thats why our US benefits and global well-being resources are designed to support youat 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 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 persons 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 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

Were 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 .

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 applicants 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.