Sr. Director, Regulatory Strategy

6 days ago

Bethesda, United States Moderna Full time

The Role:

Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy for the COVID-19 franchise to be based in its Cambridge headquarters or one of Moderna’s East Coast hubs. This role is intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for and licensure maintenance of messenger RNA COVID-19 vaccines. The Sr. Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing regulatory plans for programs within the assigned franchise, and as an expert within Regulatory, will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate, accounting for the complex interplay between major global Health Agencies, and leveraging the mRNA platform technology. Prior regulatory experience with infectious disease & vaccine development preferred.

Here's What You’ll Do:

  • Serve as overall global regulatory lead accountable for all regulatory aspects of the COVID-19 franchise, including development and implementation of the global regulatory strategy and plans for programs within the franchise.
  • Advises project teams regarding the development and implementation of regulatory strategy throughout each program’s life cycle.
  • Ensures delivery of activities essential to maintain regulatory compliance and license to operate in countries worldwide where mRNA COVID-19 vaccines are authorized or licensed.
  • Ensures regulatory commitments are managed and addressed in a compliant, timely and high quality manner.
  • Ensures alignment of regulatory activities with franchise priorities, alignment of regulatory risk mitigation plans across relevant sub-functions, and shared ownership of regulatory deliverables.
  • Overall accountable for the preparation, submission, and follow-up of regulatory documents to health authorities.
  • Responsible for ensuring regulatory risks, mitigation and contingency plans are aligned within the function prior to governance.
  • Monitor and interpret changes in the regulatory environment, especially related to the mRNA platform with focus on vaccine development, and communicates potential impact to internal teams.
  • Liaise with health authorities, internal stakeholders, and external partners to ensure business objectives are achieved as defined.
  • Establishes and maintains excellent relationships with global health agencies.
  • Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly and effectively with health agencies regarding company's filings.
  • Reviews and approves dossier content prior to submission to regulatory authorities.
  • Serves as regulatory affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
  • Identify areas in need of improvement and lead the development and implementation of process improvements.
  • Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables.
  • Manages a team of Regulatory strategists that are responsible for the portfolio deliverables and act as Global Regulatory leads or delegates for specific programs.

Here’s What You’ll Bring to the Table:

  • BA/BS degree in a scientific/engineering discipline. Advanced degree Preferred.
  • 12+ years of experience in the Pharmaceutical industry.
  • 8+ years of experience in Regulatory strategy, including specifically: Vaccine Development.
  • Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to Infectious Disease vaccine programs.
  • Strong experience with CTD format and content regulatory filings.
  • Experience with developing and implementing competitive regulatory strategies.
  • Demonstrated track record in securing product approvals and maintaining a complex portfolio.
  • Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance – preferably from at least both US and EU.
  • 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.
  • Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.).
  • Ability to work independently to manage multiple projects in a fast-paced environment.
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones.
  • Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory bodies.
  • Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Affairs the Project Team and senior management, as relevant.
  • May be responsible for line management and development of direct reports.
  • Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.
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