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Associate Director, Global Regulatory Labeling

Company: BioSpace, Inc.
Location: Cambridge
Posted on: June 5, 2024

Job Description:

Job Details

The Role:

Moderna Therapeutics is seeking an Assoc. Director of Regulatory Labeling to support current and existing programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward-looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for products to new markets.

The Associate Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory labeling, especially the generation of new US prescribing information and changes to existing labeling, and submission of labeling information to Health Agencies.

Heres What Youll Do:

  • Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.
  • Direct the labeling control process for tracking, implementation, and regulatory submission of changes to existing labeling.
  • Develops labeling content, format and accountability for regulatory submissions (BLAs/MAAs) and related supplements and amendments. Ensure that new labeling text meets regulatory labeling requirements.
  • Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
  • Direct submission of labeling materials and supporting documentation to regulatory agencies in accordance with submission requirements.
  • Serve as a Labeling expert in Regulatory Affairs sub-teams for activities related to the development of labeling for regulatory submissions.
  • Effectively communicate the regulatory labeling strategy, risks, mitigations and overall plans to the Regulatory Affairs Management Team, Project Development Team and senior management, as relevant.
  • Partner with the Global Regulatory Lead to develop Target Label Profiles to support all phases of clinical development (Phase 1-4).
  • Provide input to the end-to-end labeling process.
  • Liaise within the pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and trends; and influence the industry environment regarding medical writing and labeling.
    • May be responsible for line management and development of direct reports in the future. Heres What Youll Need:
      • BA/BS degree in a scientific discipline required, Masters or PhD preferred.
      • 10+ years of experience in the Pharmaceutical industry
      • 6+ years of experience in Regulatory labeling
      • Strong knowledge of current US and EU regulations, including specifically: e.g. vaccine development regulations and registration pathways.
      • Strong experience with CTD format and content regulatory filings
      • Exceptional written and oral communication
      • Experience dealing with a broad range of stakeholders at all levels internal and external to the company
      • Delivery of labeling for at least one major application (NDA/BLA/MAA/JNDA, etc.) Heres What Youll Bring to the Table
        • Experience facilitating meetings and driving consensus and results.
        • Excellent leadership, communication (verbal and writing) and collaboration skills.
        • Proven ability in medical/technical writing.
        • Labeling experience (CCDS, US, EU) in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation is desirable.
        • Integrity: overriding commitment to integrity and high standards in self and others.
        • Achievement or Result Orientation: a concern for working well or for surpassing a standard of excellence.
        • Strategic orientation: the ability to link visions and daily work
        • Communication: ability and intend to effectively explain, describe or convey information to a variety of audiences. Specifically, interacts effectively as a member of the Regulatory sub-team, communicates effectively strategies to the Global Labeling Committee and collaborates with business partners, including affiliates and third parties.
        • Develops others: involved in a genuine intent to foster the development of others; mentoring
        • Flexibility/adaptability: ability to adapt to, and work effectively within a variety of situations and with various individuals or groups.
        • Relationship building, teamwork and cooperation: builds or maintains friendly relationships with people and demonstrates a desire to work.
        • Problem-solving and analytical Thinking: understand a situation by breaking it apart into small pieces or tracing the implications of a situation in a step-by-step way. Systematically organizing the parts of a problem. 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)

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Keywords: BioSpace, Inc., Cambridge , Associate Director, Global Regulatory Labeling, Executive , Cambridge, Massachusetts

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