Director, Global Regulatory Strategy, Oncology

About the role

Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the rare, autoimmune, and oncology portfolios. This newly created role is intended for a forward-looking, creative regulatory strategist able to anticipate and address the challenges involved in developing and gaining market approval for messenger RNA products in the U.S. and other markets. The Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing regulatory plans for assigned programs. As an expert within Regulatory, you will articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate.

Responsibilities

• Serve as global regulatory lead accountable for all regulatory aspects of assigned program(s), including development and implementation of the global regulatory strategy plan for the program.
• Represent Regulatory Science on cross-functional program teams.
• Ensure the global regulatory strategy for assigned program(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 Global Regulatory Science Leadership Team, Project Development Team, and senior management, as relevant.
• Collaborate with internal teams and Moderna partners to achieve program goals, including development content and management of submissions to Health Agencies.
• Set strategic direction and lead the development of content, format, and accountability for regulatory submissions and related amendments.
• Monitor regulatory developments related to mRNA platform and advise program teams regarding the development and implementation of regulatory strategy through the clinical development processes.
• Conduct risks and gaps assessments and identify potential areas of regulatory concern; respond to new government/regulatory developments.
• Establish and maintain excellent relationships with regulatory agency personnel.
• Negotiate directly and effectively with health agencies regarding company's filings; respond to requests for additional data, organize, and manage participation in meetings.
• Review and approve technical data and verify accuracy of clinical data and execution of clinical projects to regulatory authorities.
• Develop, implement, and review current policies and practices in compliance with Federal and international regulatory agencies.
• Monitor regulatory intelligence and publications to keep apprised of new or changing regulatory developments and potential strategic impact.
• Serve as regulatory science representative to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
• Support 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.
• Manage resources for assigned program(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the program deliverables.

Requirements

• BA/BS degree in a scientific/engineering discipline required; PharmD, Masters, or PhD preferred.
• 10+ years of experience in the Pharmaceutical industry.
• 8+ years of experience in Regulatory strategy.
• 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 programs 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 willingness to share knowledge and lessons learned.

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.

Pay

The salary range for this role is $167,000.00 - $300,700.00. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

Schedule

Moderna champions an in-person culture with a 70/30 work model, where 70% of the work is conducted in-office to foster innovation, teamwork, and direct mentorship.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.