Sr. Director, Regulatory Strategy, Infectious Disease

Moderna • Bethesda, MD

9d • $196,700 - $353,400 • Hybrid

About The Position

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.

Requirements

• 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.
• 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 responsible for line management and development of direct reports.
• 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 knowledge and lessons learned.

Nice To Haves

• Advanced degree
• Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)

Responsibilities

• 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.

Benefits

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Family planning benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

What This Job Offers

• Job Type: Full-time
• Career Level: Director