Director, Global Regulatory Strategy, Oncology

The Role:

Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the rare, autoimmune and oncology portfolios. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in developing and gaining market approval for messenger RNA products 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.

Prior regulatory experience with therapeutics development is preferred.

• Serve as global regulatory lead accountable for all regulatory aspects of his or her assigned program(s), including development and implementation of the global regulatory strategy plan for the program
• Represent Regulatory Science on cross-functional program teams.
• Ensure the global regulatory strategy for assigned program(s) is consistent with the business objectives and have been negotiated with relevant health authorities as appropriate.
• Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the Global Regulatory Science Leadership Team, Project Development Team and senior management, as relevant.
• Collaborates with internal teams and Moderna partners as relevant to achieve program goals, including development content and management of submissions to Health Agencies.
• Sets strategic direction and leads the development of content, format and accountability for regulatory submissions and related amendments.
• Monitors regulatory developments related to mRNA platform and advises program teams regarding the development and implementation of regulatory strategy through the clinical development processes.
• Conducts risks and gaps assessment and identifies potential areas of regulatory concern and responds to new government/regulatory developments.
• Establishes and maintains excellent relationships with regulatory agency personnel.
• Negotiates directly and effectively with health agencies regarding company's filings. Responds to requests for additional data, organizes and manages participation in meetings.
• 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.
• Monitors regulatory intelligence and publications to keep apprised of new or changing regulatory developments and potential strategic impact.
• Serves as regulatory science representative to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
• Supports development and maintenance of the Target Label Profile and the Company Core Data Sheet.
• Identifies areas in need of improvement and lead the development and implementation of process improvements
• Manages resources for assigned program(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the program deliverables.

• BA/BS degree in a scientific/engineering discipline required. PharmD, Masters or PhD preferred.
• 10+ years of experience in the Pharmaceutical industry
• 8+ years of experience in Regulatory strategy
• Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to Oncology 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 is preferred
• 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…