Senior Director, Global Regulatory Strategy, Oncology
Listed on 2026-07-11
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Business
Regulatory Compliance Specialist
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.
Here’s What You’ll Do- 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
- 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
What You’ll Bring to the Table (Preferred 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.)
- 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
The salary range for this role is $ - $. 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…
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