We have other current jobs related to this field that you can find below

  • Senior Manager, Global Regulatory Science CMC

    2 months ago

    Norwood, Massachusetts, 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...

  • 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...

  • Senior Manager, Global Regulatory Science CMC

    2 weeks ago

    Norwood, United States BioSpace, Inc. Full time

    Job Details 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...

  • Senior Manager, Global Regulatory Science CMC

    2 months ago

    Norwood, United States Moderna 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...

  • Director, Global Regulatory Science, CMC

    3 months ago

    Norwood, United States Moderna, Inc. Full time

    The Role:The Director, Global Regulatory-CMC will be responsible for leading regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Director may manage a small group of individuals responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to...

  • Director, Global Regulatory Science CMC

    3 weeks ago

    Norwood, Massachusetts, United States Moderna, Inc. Full time

    The Role:The Director, Global Regulatory-CMC will be responsible for leading regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Director may manage a small group of individuals responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to...

  • Associate Director, Global Regulatory Science, CMC

    3 months ago

    Norwood, Massachusetts, United States Moderna, Inc. Full time

    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...

  • Associate Director, Global Regulatory Science, CMC

    3 months ago

    Norwood, United States Moderna, Inc. Full time

    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...

  • Associate Director, Global Regulatory Science, CMC

    3 months ago

    Norwood, United States Moderna, Inc. Full time

    The Role:The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for a commercial product, including most notably, post-approval variations. The Associate Director will be responsible for developing US regulatory CMC strategies and collaborating with key stakeholders to execute the...

  • Director, Global Regulatory Science CMC

    2 months ago

    Norwood, United States Moderna, Inc. Full time

    The Role:The Director, Global Regulatory-CMC will be responsible for leading regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Director may manage a small group of individuals responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to...

  • Associate Director, Global Regulatory Science CMC, Therapeutics Programs

    3 days ago

    Norwood, United States Moderna, Inc. Full time

    The Role:The Associate Director, Global Regulatory Science CMC Therapeutics Programs, will be responsible for leading regulatory CMC strategy and support for products in clinical development (IND, CTA) and commercial product registrations (BLA, MAA), including, post-approval variations. The Associate Director will be responsible for developing regulatory...

  • Associate Director, Global Regulatory Science

    3 months ago

    Norwood, United States Moderna, Inc. Full time

    The Role:The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for a commercial product, including most notably, post-approval variations. The Associate Director will be responsible for developing US regulatory CMC strategies and collaborating with key stakeholders to execute the...

  • Sr. Statistician, CMC Quantitative Sciences

    3 months ago

    Norwood, United States Moderna, Inc. Full time

    The RoleIn this role, you will provide strategic statistical guidance and leadership to project teams. Working collaboratively with cross-functional teams, you will partner with colleagues in Process Development, Analytical Development, Quality, Manufacturing, and Nonclinical Research. Your understanding of these domains will be essential in identifying the...

  • Principal Statistician, CMC Quantitative Science

    3 months ago

    Norwood, United States Moderna, Inc. Full time

    The RoleModerna is seeking an accomplished Principal Statistician to join our Chemistry, Manufacturing, and Controls (CMC) Quantitative Sciences team onsite in Norwood, MA. As a pivotal member of the CMC Statistics team, you will provide strategic statistical guidance and leadership to project teams.Working collaboratively with cross-functional teams, you...

  • Associate Director, CMC Program Management

    2 months ago

    Norwood, United States Moderna, Inc. Full time

    The RoleThe CMC Program Management team in Technical Development seeks an Associate Director to lead pivotal work focusing on the design and comprehensive management of CMC program integrated project plans. The candidate is expected to be a trend setter of cross-functional communication, aligning priorities for optimal project execution while demonstrating...

  • Associate Director, CMC Program Management

    3 weeks ago

    Norwood, United States BioSpace, Inc. Full time

    Job Details The Role The CMC Program Management team in Technical Development seeks an Associate Director to lead pivotal work focusing on the design and comprehensive management of CMC program integrated project plans. The candidate is expected to be a trend setter of cross-functional communication, aligning priorities for optimal project execution while...

  • Director, Clinical CMC Finance

    3 months ago

    Norwood, Massachusetts, United States Moderna, Inc. Full time

    The Role:This role is an exciting opportunity to be a critical part of the talent engine fueling a high growth organization that has rapidly developed and commercialized Spikevax and, has the potential to launch up to twenty-two products by 2028.Moderna is looking for aDirector, Clinical CMC Finance to become the finance leader for our Technical Development...

  • Director, Clinical CMC Finance

    3 months ago

    Norwood, United States Moderna, Inc. Full time

    The Role:This role is an exciting opportunity to be a critical part of the talent engine fueling a high growth organization that has rapidly developed and commercialized Spikevax and, has the potential to launch up to twenty-two products by 2028.Moderna is looking for aDirector, Clinical CMC Finance to become the finance leader for our Technical Development...

  • Regulatory Affairs Manager

    2 months ago

    Norwood, United States BioTalent Full time

    IntroductionBioTalent is representing a top-tier life sciences device manufacturer hiring a Regulatory Affairs Manager ensure compliance with global regulatory requirements while managing the regulatory affairs team. The role requires collaboration with product development, quality assurance, and other cross-functional teams to support the organization's...

  • HR Partner, CMC

    2 months ago

    Norwood, Massachusetts, United States Moderna, Inc. Full time

    The Role:This role is an exciting opportunity to be a critical part of the people and talent engine fueling a high growth organization that is radically changing the biotech industry. The HR Partner, CMC must be a HR professional who is able to work effectively with employees in CMC, while also ensuring the efficient and effective execution of key Human...

Sr. Manager, Regulatory Science, CMC

2 months ago

Norwood, United States BioSpace, Inc. Full time

Job Details

The Role:

The Sr. Manager, Global Regulatory CMC will be support regulatory CMC activities for one or more programs. 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. 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 develop 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 Bring to the Table:

Minimum Qualifications

BA/BS degree in a scientific/engineering discipline 6+ years of experience in the Pharmaceutical industry 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 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 leavesandaccommodations@modernatx.com . (EEO/AAP Employer) #LI-LG1 - #J-18808-Ljbffr