Director of Regulatory Strategy

4 weeks ago

Cambridge, Massachusetts, United States BioSpace, Inc. Full time
Job Opportunity

The Role:

Moderna is seeking a Director of Regulatory Strategy to develop and lead global strategy for mRNA vaccines. This role is intended for a forward-thinking, creative regulatory strategist able to anticipate and address challenges in clinical development and gain market approval for mRNA vaccines.

The Director will be a strategic leader within Global Regulatory Science, articulating clear and compelling regulatory strategy, highlighting risks and opportunities, and accounting for the complex interplay between major global health agencies. Prior regulatory experience with infectious disease and vaccine development is preferred.

Key Responsibilities:

  • Develop and implement global regulatory strategy and plans for mRNA vaccines.
  • Advise project teams on regulatory strategy through all stages of the product development lifecycle.
  • Ensure global regulatory strategy is aligned with business objectives and negotiated with relevant health authorities.
  • Develop and implement regulatory risk assessment and mitigation plans.
  • Prepare, submit, and follow up on regulatory documents to health authorities.
  • Liaise with health authorities, internal stakeholders, and external partners to achieve business objectives.
  • Respond to requests for additional data, organize and manage participation in meetings, and negotiate directly with health agencies.
  • Review and approve regulatory documents and dossiers prior to submission.
  • Support development and maintenance of the Target Label Profile and Company Core Data Sheet.
  • Monitor and interpret changes in the regulatory environment and communicate potential impact to internal teams.
  • Identify areas for improvement and lead the development and implementation of process improvements.
Requirements:

  • BA/BS degree in a scientific or engineering discipline, advanced degree preferred.
  • 10+ years of experience in the pharmaceutical industry.
  • 6+ years of experience in regulatory strategy, including vaccine development.
  • Expert knowledge of relevant FDA, EU, and ICH guidelines and regulations related to infectious disease vaccine programs.
  • Strong experience with CTD format and content of regulatory filings.
  • Experience with developing and implementing competitive regulatory strategies.
  • Demonstrated track record in maintaining a complex portfolio.
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development and product registration.
  • Direct experience of leading regulatory authority meetings in different phases of drug development.
  • Regulatory knowledge across therapeutic areas, including infectious diseases and vaccine development, is preferable.
  • Ability to work independently to manage multiple projects in a fast-paced environment.
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory bodies.
  • Effectively communicates the regulatory strategy, risks, mitigations, and overall plans to Regulatory Affairs, the Project Team, and senior management.
  • Identify areas for improvement and lead the development and implementation of process improvements.
Benefits:

  • Comprehensive and innovative suite of benefits, including medical, dental, and vision coverage options.
  • Flexible Spending Accounts for medical expenses and dependent care expenses.
  • Lifestyle Spending Account funds to help with 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:

Moderna is a leading mRNA technology platform company, committed to building a world-class team and creating a culture of belonging. We believe in giving our people a platform to change medicine and the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. We are proud to have been recognized as a Science Magazine Top Biopharma Employer and a Fast Company Best Workplace for Innovators. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

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