Director/Sr. Director, Regulatory Strategy, Infectious Diseases/Vaccines
Moderna Therapeutics is seeking a Director/Sr. Director of Regulatory Strategy to support rare disease 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 therapeutics as unprecedented new drug modality. The Director/Sr. Director will be a strategic leader within Regulatory Affairs, 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.
- Develops 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 development processes. Identifies potential areas of regulatory concern and responds to new government/regulatory developments.
- Establishes and maintains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities 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 affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
- Coordinates with other departments, corporate or marketing partners, and outsourcing partners to achieve project goals.
- Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
- Reviews all external materials for regulatory compliance.
- Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory bodies.
- Serve 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
- Represent Regulatory Affairs on cross-functional project teams
- Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the GRA Management Team, Project Development Team and senior management, as relevant.
- Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevant health authorities as appropriate.
- Ensure alignment of regulatory strategy and plan on a continuous basis within the Moderna ecosystem.
- 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.
- Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables.
- BA/BS degree in a scientific/engineering discipline
- 15+ years of experience in the Pharmaceutical industry
- 8+ years of experience in Regulatory strategy, including specifically: infectious diseases/vaccines
- Strong knowledge of current US and EU regulations, including specifically: e.g. novel regulatory pathways.
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
- Experience with developing and implementing competitive regulatory strategies
- Demonstrated track record in securing product approvals and maintaining a complex portfolio
- Experience dealing with broad range of stakeholders at all levels internal and external to the company
- Demonstrated competence in employee management and development
- 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 in a number of therapeutic areas
- Graduate degree in a scientific discipline or other relevant graduate discipline or professional certification
- Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)