Sr. Director, Regulatory Strategy, Infectious Disease

Moderna; Cambridge (MA); On-site; USD 250,000 - 340,000; Full time

Job summary

Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead global regulatory programs from its Cambridge headquarters or East Coast hubs.

The role focuses on gaining market approval for mRNA infectious disease vaccines, leveraging global health agency interactions and regulatory expertise. The Sr. Director will guide regulatory strategy, manage submissions, and coordinate with internal teams to ensure successful development and approvals while navigating US and EU requirements and

Qualifications

• BA/BS degree in a scientific/engineering discipline; advanced degree preferred.
• 12+ years of experience in the Pharmaceutical industry.
• 8+ years in Regulatory strategy, including Vaccine Development.
• Expert knowledge of FDA, EU, ICH guidelines and regulations for Infectious Disease vaccine programs.
• Strong experience with CTD format and content regulatory filings.
• Experience developing and implementing competitive regulatory strategies.
• Proven track record securing product approvals and managing a complex portfolio.
• Knowledge of regulatory procedures for US and EU drug development and registrations.
• Direct experience leading regulatory authority meetings.

Responsibilities

• Sets strategic direction and leads regulatory submissions and related supplements and amendments.
• Advises project teams on regulatory strategy through development processes.
• Identifies regulatory risks and responds to new government developments.
• Monitors regulatory developments related to mRNA vaccine programs.
• Maintains relationships with global health agencies and negotiates with authorities.
• Reviews technical data and verifies accuracy of clinical data for filings.
• Helps plan trials and filing activities and ensures report systems are compliant.
• Collaborates with internal teams and Moderna partners to manage submissions.

Skills

Regulatory strategy

FDA regulations

EU regulations

Vaccine development

CTD format

Cross-functional leadership

Education

BA/BS in science or engineering

Advanced degree preferred

Tools

CTD format

Job description

The Role:

Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters or one of Moderna's East Coast hubs. This role is intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA infectious disease vaccines as unprecedented new drug modality globally.

The Sr. 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, accounting for the complex interplay between major global Health Agencies, and leveraging the mRNA platform technology. Prior regulatory experience with infectious disease & vaccine development preferred.

Here's What You'll Do:

• 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.
• Conducts risks and gaps assessment and Identifies potential areas of regulatory concern and responds to new government/regulatory developments.
• 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 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 in partnership with RA CMC and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities.
• Provides input on trials and filing activities and ensures that report systems are maintained and compliant.
• Collaborates with internal teams globally and Moderna partners to achieve project goals, including development content and management submissions to Health Agencies.
• Demonstrates strong cultural awareness and sensitivity, value diverse perspectives and experiences, and foster an inclusive environment where all individuals feel respected and heard.
• 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
• 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
• Manages a team of Regulatory strategists that are responsible for the portfolio deliverables for COVID facing programs

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

• BA/BS degree in a scientific/engineering discipline. Advanced degree Preferred.
• 12+ years of experience in the Pharmaceutical industry
• 8+ 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 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 effectively 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.
• May be