Senior Director, Global Regulatory Strategy, Oncology

About the role

The role Moderna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and registration strategies.

Responsibilities

• Lead global regulatory strategies from early development through commercialization
• Drive regulatory submissions (INDs, CTAs, BLAs/MAAs) with excellence and urgency
• Lead health authority interactions (FDA, EMA, PMDA), including high-stakes negotiations
• Shape strategies for novel and first-in-class therapies
• Partner cross-functionally and across alliances to align on strategy
• Anticipate regulatory risks and proactively mitigate them
• Build and develop high-performing regulatory teams
• Continuously elevate strategic thinking across programs and stakeholders
• Interpret health authority feedback through a trend-based, cross-program lens
• Connect individual HA interactions to a broader regulatory narrative
• Bring regulatory thinking earlier into research and development and define success upfront
• Proactively identify risks before they emerge in HA feedback
• Navigate novel endpoints and evolving evidentiary frameworks
• Operate effectively in complex global regulatory environments with limited precedent
• Develop teams to operate with independence and strong strategic judgment

Requirements

• BA/BS degree in a scientific/engineering discipline
• 12+ years of experience in the Pharmaceutical industry
• 8+ years of experience in Regulatory strategy, including oncology
• Strong knowledge of current US and EU regulations, including specifically: e.g. novel regulatory pathways
• Strong experience with CTD format and content regulatory filings
• Exceptional written and oral communication
• Experience with developing and implementing competitive regulatory strategies
• Demonstrated track record in securing product approvals and maintaining a complex portfolio
• Experience dealing with broad range of stakeholders at all levels internal and external to the company
• Demonstrated competence in employee management and development
• 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

Qualifications

• Graduate degree in a scientific discipline or other relevant graduate discipline or professional certification
• Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)

Skills

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

Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between. Best-in-class healthcare coverage, 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 investment opportunities to help you plan for the future. Location-specific perks and extras.

Pay & Benefits

The salary range for this role is $196,700.00 - $353,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. 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.

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. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position.