Associate Director, Global Regulatory Strategy - Oncology (INT)

The Role:

Moderna, Inc. is seeking an Associate Director of Regulatory Strategy to support INT within the Oncology programs. 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 oncology products as unprecedented new drug modality in the U.S. and other markets. The Associate 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 Oncology development preferred.

Here's What You’ll Do:

• Serve as 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.

• 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.

• Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the Regulatory Affairs Management Team, Project Development Team and senior management, as relevant.

• Collaborates with internal teams and Moderna partners to achieve project 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 supplements and amendments.

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

• 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 regulatory agency personnel.

• 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.

• Monitors regulatory 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.

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

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

• BA/BS degree in a scientific/engineering discipline required. PharmD, Masters or PhD preferred.

• 8+ years of experience in Regulatory strategy, including specifically: Oncology Development

• 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 knowledge across therapeutic areas including Oncology 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 program’s critical regulatory milestones.

• Outstanding communication skills (verbal and written) and willing