Senior Manager, CMC Regulatory Affairs

The Role:
The candidate in this role will be based at the Norwood MA site and will be responsible for preparing and overseeing CMC and Quality related agency correspondence and regulatory applications as well as govern CMC submissions and regulatory compliance support for the development of global products. This position will lead and support all regulatory activities to provide high quality CMC sections of regulatory documentation. 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.

Heres What Youll Do:

• Support 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

• Contribute in the Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions

• Support regulatory processes and procedures to support CMC components of regulatory submissions

• Support the creation and maintenance of CMC submission templates

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

• Provides interpretation of regulatory guidance documents regulations and directives advises Manufacturing Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs

Heres What Youll Need (Basic Qualifications)

• MS degree in Pharmaceutics Chemistry Chemical Engineering or closely related field is desirable

• 10 years of experience in the pharmaceutical/biotech industry manufacturing and/or analytical focus

• 5 years of experience in focused Regulatory CMC preferably Biologics based

• Multidisciplinary focus on certain therapeutic areas (vaccines oncology and/or rare diseases)

• Strong knowledge of current US EU and ROW regulations

• Strong knowledge of cGMP

• Strong experience with CTD format and content regulatory filings

• Exceptional written and oral communication

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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