Senior Director, Global Regulatory Strategy, Oncology

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

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 filing; 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 have

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.); Acts with urgency and delivers results with excellence; Thinks and operates as an enterprise leader; Challenges convention and drives innovation; Makes high-quality decisions under ambiguity and pressure; Builds and develops high-performing, accountable teams; Influences effectively across internal and external stakeholders

Benefits

Competitive healthcare, plus voluntary benefit programs; 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; The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award