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.

Here’s What You’ll 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 manufacturing and 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

Here’s What You’ll 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.  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 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

The salary range for this role is $130,800.00 - $209,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

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