Executive Director, CMC Regulatory Science

The Role:

The individual in this position will be based at 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 be required to 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.

Heres What Youll Do:

• 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

• Provides CMC regulatory expertise to manufacturingand quality teams; evaluates CMC change controls

• Provides interpretation of domestic and international regulatory guidance documents regulations and directives advises 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

Heres What Youll Need (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

Heres What Youll Bring to the Table (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

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 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

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 .

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