Director, Global Regulatory Strategy - Infectious Diseases, RSV

The Role:

Moderna, Inc. is seeking a Director of Regulatory Strategy to develop and lead global strategy for mRESVIA, Moderna’s late stage / marketed RSV messenger RNA (mRNA) vaccine (Adult indication) to be based in one of Moderna’s East Coast hubs. The Global Regulatory Lead (GRL) role is intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in expanding the Adult indication, the geographical footprint of the vaccine and gaining market approval for lifecycle and licensure maintenance of mRESVIA.  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.  The Director will provide strategic direction and guidance to the teams. They set the vision, goals, and priorities for regulatory affairs within the organization. The GRL will demonstrate ability to collaborate effectively with cross-functional teams, including research and development, compliance, and marketing. They influence decision-making by providing regulatory insights.

Prior regulatory experience with infectious disease & vaccine development and clinical development is strongly preferred.

Here's What You’ll Do:

• Serve as global regulatory lead accountable for all regulatory aspects of Moderna’s RSV mRNA vaccine focused on the Adult indication, including development and implementation of the global regulatory strategy and plans for indication expansion, geographical expansion, and licensure maintenance worldwide.

• Working in partnership with a cross-functional team, demonstrated track record of successful collaboration with a team of experts, transparent communication kills and lead/coach of a team of Regulatory professionals

• Liaises with cross-functional team members to ensure implementation of regulatory strategy.

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

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

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

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

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

• Supports development and maintenance of the Company Core Data Sheet and local prescribing information for assigned program.

• Monitor and interpret changes in the regulatory environment, especially related to the mRNA platform with focus on vaccine development, and communicates 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 regulatory filings

• Experience with developing and implementing competitive regulatory strategies 

• Demonstrated track record in securing product approvals and maintaining a complex portfolio

• 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 infectious diseases a