Associate Director, Global Regulatory Science, CMC

Norwood, MA, United States

Job Details

The Role:

The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for one or more programs. The Associate Director will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with regulatory requirements and business priorities. The individual will be expected to provide guidance to CMC teams and collaborate within the Global Regulatory Science CMC team. The Associate Director will be responsible for preparation of CMC and Quality related Health Authority correspondence and regulatory submissions. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on maintaining a new, transformative medicine for patients. The Associate Director can be based at Norwood or Cambridge, MA or Basel, Switzerland sites.

Heres What Youll Do:

Develop and implement effective regulatory CMC strategies for global IND/CTA/BLA/MAA

Identify regulatory risks and mitigation strategies

Provide regulatory CMC advice to manufacturing and quality teams

Review documents for submission-readiness, to ensure that all submissions conform to global Health Authority regulatory requirements

Lead regulatory CMC discussions and interactions with Health Authorities to facilitate review and approval of submissions

Assess change controls related to quality/manufacturing changes

Support development of regulatory processes and procedures

Support the creation and maintenance of CMC submission tools and templates

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 Bring to the Table:

BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required

8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus

5+ years of experience in Biologics focused Regulatory CMC

Strong knowledge of current US CMC regulations, including CTD format and content of CMC regulatory submissions

Knowledge of current CMC regulations outside of the US, as well, is preferred

Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects of drug development, product registration, and post-approval lifecycle management (LCM)

Ability to effectively collaborate in a dynamic, cross-functional matrix environment to meet critical regulatory milestones

Ability to work independently

Exceptional written and oral communication

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 options

Flexible Spending Accounts for medical expenses and dependent care expenses

Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities

Family care benefits, including subsidized back-up care options and on-demand tutoring

Free premium access to fitness, nutrition, and mindfulness classes

Exclusive preferred pricing on Peloton fitness equipment

Adoption and family-planning benefits

Dedicated care coordination support for our LGBTQ+ community

Generous 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 thereafter

Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents

401k match and Financial Planning tools

Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options

Complimentary concierge service including home services research, travel booking, and entertainment requests

Free parking or subsidized commuter passes

Location-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 [email protected] . (EEO/AAP Employer)

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