Director, Regulatory Strategy, Latent Viruses

The Role:

Moderna is seeking a Director of Regulatory Strategy to develop and lead global strategy for Moderna’s Latent Viruses messenger RNA (mRNA) vaccines to be based in Bethesda or Cambridge.

This is a role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in clinical development and to gain market approval for mRNA Latent Viruses vaccines.  

The Director will be a strategic leader within Global Regulatory Science, 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 is preferred.

Here's What You’ll Do:

• Serve as global regulatory lead accountable for all regulatory aspects of Latent Viruses vaccines, including development and implementation of the global regulatory strategy and plans. 

• Advise project teams regarding the development and implementation of regulatory strategy through all stages of the product’s development lifecycle.

• Ensure the global regulatory strategy for assigned project(s) is aligned with the business objectives and have been negotiated with relevant health authorities as appropriate. 

• Ensure regulatory risk assessment and mitigation plans are developed and aligned across functions.

• Set strategic direction and overall accountable for the preparation, submission, and follow-up of regulatory documents to health authorities for assigned program(s). 

• Liaise with health authorities, internal stakeholders, and external partners to ensure business objectives are achieved as defined. 

• Respond to requests for additional data, organize and manage participation in meetings. Negotiate directly and effectively with health agencies regarding company's filings.

• Review and approve regulatory documents and dossiers prior to submission to regulatory authorities.

• Support development and maintenance of the Target Label Profile and the Company Core Data Sheet for assigned program(s).

• Monitor and interpret changes in the regulatory environment, especially related to the mRNA platform with focus on vaccine development, and communicate potential impact to internal teams. 

• 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. 

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

• BA/BS degree in a scientific/engineering discipline.  Advanced degree Preferred.

• 10+ years of experience in the Pharmaceutical industry

• 6+ 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 of regulatory filings

• Experience with developing and implementing competitive regulatory strategies 

• Demonstrated track record in maintaining a complex portfolio

• Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration,– 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 program’s 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 Regulatory Affairs, the Project Team and senior management, as relevant.

• 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 k