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Associate Director, Global Regulatory, CMC

Company: Moderna Therapeutics Inc.
Location: Cambridge
Posted on: May 24, 2023

Job Description:

The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending on complexity, through all stages of a products lifecycle. The Associate Director will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with business priorities. The individual will be expected to provide guidance to the product teams and will be responsible for preparation of CMC and Quality related agency correspondence and regulatory applications. 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. Development of regulatory strategy for the products in our portfolio will be a key success component. The Associate Director will be based at the Norwood, MA site.Here's What You'll Do:

  • Develop/implement effective CMC regulatory strategies for global 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
  • Lead Regulatory CMC discussions and interactions with health authorities to facilitate review and approval of submissions
  • Perform assessment of manufacturing change controls
  • Support development of 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 programsHere's What You'll 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 Global CMC regulations, including with CTD format and content of CMC regulatory submissions
    • Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects for drug development, product registration, line extension and license maintenance
    • Ability to effectively collaborate in a dynamic, cross-functional matrix environment to drive meeting each program's critical regulatory milestones
    • Ability to work independently
    • Exceptional written and oral communicationModerna 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 ModernaIn over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit 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. We're 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at (EEO/AAP Employer)#LI-LG1-

Keywords: Moderna Therapeutics Inc., Cambridge , Associate Director, Global Regulatory, CMC, Executive , Cambridge, Massachusetts

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