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Director, Global Regulatory Strategy, Infectious Disease

Employer
Moderna, Inc.
Location
Cambridge, MA
Start date
Oct 1, 2022

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Job Details

The Role:

Moderna, Inc. is seeking a Director of Regulatory Strategy to support Infectious Diseases/Vaccines programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA infectious disease vaccines as unprecedented new drug modality in the U.S. and other markets. The Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing regulatory plans for assigned programs, 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 Youll Do:

  • Sets strategic direction and leads the development of content, format and accountability for regulatory submissions and related supplements and amendments.

  • Advises project teams regarding the development and implementation of regulatory strategy through the clinical and nonclinical development processes.

  • Conducts risks and gaps assessment and Identifies potential areas of regulatory concern and responds to new government/regulatory developments.

  • Monitors regulatory developments related to mRNA platform with focus on vaccine development and advises project teams regarding the development and implementation of regulatory strategy through the clinical development processes.

  • 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 technical data and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.

  • Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies.

  • Serves as regulatory science executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.

  • Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.

  • Supports development and maintenance of the Target Label Profile and the Company Core Data Sheet.

  • Collaborates with internal teams and Moderna partners to achieve project goals, including development content and management submissions to Health Agencies.

  • Serves as overall global regulatory lead accountable for all regulatory aspects of his or her assigned project(s), including development and implementation of the global regulatory development plan for the project.

  • Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevanthealth authorities as appropriate

  • 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

Heres What Youll 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 collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each programs 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 Global Regulatory Science, the Project Team and senior management, as relevant.

  • May be responsible for line management and development of direct reports.

  • Identify areas in need of improvement and lead the development and implementation of process improvements.

  • Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned.

Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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