Sr. Director, Global Regulatory Strategy, Oncology

About the role

The Role Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology 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 a novel drug modality. The 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 global regulatory strategies, highlighting risks and opportunities when appropriate, accounting for the complex interplay between major global Health Agencies, and leveraging the mRNA platform technology.

Responsibilities

• 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.
• Identifies potential areas of regulatory concern and responds to new government/regulatory developments.
• 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 affairs 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.
• Ensures development and maintenance of the Target Label Profile and the Company Core Data Sheet for their program(s).
• Reviews all external materials for regulatory compliance.
• 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 relevant health authorities as appropriate
• 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

Qualifications

• BA/BS degree in a scientific/engineering discipline
• 12+ years of experience in the Pharmaceutical industry
• 8+ years of experience in Regulatory strategy, including oncology
• 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