Senior Manager, Global Regulatory Science CMC

2 months ago

Norwood, United States Moderna, Inc. Full time

The Role:

The Sr. Manager, Global Regulatory CMC will be responsible for supporting regulatory CMC activities for one or more programs in their portfolio, including but not limited to Oncology and Rare Diseases. The Sr. Manager will provide input on regulatory CMC strategy and collaborate with key stakeholders to prepare regulatory submissions and Health Authority communications in alignment with the regulatory CMC strategy. Effective communication skills will be critical to overall success. The Sr. Manager 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 and will be based at the Norwood, MA site.

Heres What Youll Do:

Support development of 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 development of regulatory processes and procedures to facilitate 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

Support multiple programs in various therapeutic areas (vaccines, oncology and/or rare diseases)

Heres What Youll Bring to the Table:

Minimum Qualifications

BA/BS degree in a scientific/engineering discipline

6+ years of experience in the pharmaceutical/biotech industry

2.5 to 3 years of experience in Regulatory CMC

Knowledge of current US and EU regulations and cGMP

Experience with CTD format and content regulatory filings

Exceptional written and oral communication

Preferred Qualifications

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

8+ years of experience in regulatory in the pharmaceutical/biotech industry

4+ years of experience in Regulatory CMC is desirable

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

Highly competitive and inclusive medical, dental and vision coverage optionsFlexible Spending Accounts for medical expenses and dependent care expensesLifestyle Spending Account funds to help you engage in personal enrichment and self-care activitiesFamily care benefits, including subsidized back-up care options and on-demand tutoringFree premium access to fitness, nutrition, and mindfulness classesExclusive preferred pricing on Peloton fitness equipmentAdoption and family-planning benefitsDedicated care coordination support for our LGBTQ+ communityGenerous paid time off, including:
Vacation, sick time and holidays
Volunteer time to participate within your community
Discretionary year-end shutdown
Paid sabbatical after 5 years; every 3 years thereafterGenerous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents 401k match and Financial Planning toolsModerna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit optionsComplimentary concierge service including home services research, travel booking, and entertainment requestsFree parking or subsidized commuter passesLocation-specific perks and extras

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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.

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.

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.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

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 proud to be an equal opportunity workplace and is an affirmative action employer.

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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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