Senior Director, Global Regulatory Strategy, Oncology

Moderna • Cambridge, MA

1d

About The Position

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. This role requires a seasoned regulatory leader who embodies Moderna’s leadership principles: acting with urgency, challenging convention, delivering with excellence, and operating as an enterprise leader. The individual will demonstrate executive presence, deep functional expertise, and a strong execution track record while elevating strategic impact across programs.

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

Nice To Haves

• 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.)

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

Benefits

• 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

What This Job Offers

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