Senior Director, Regulatory Strategy

The Senior Director, Regulatory Strategy leads global regulatory strategies for priority programs from early development through registration and lifecycle. The role anticipates requirements, shapes development plans and labels, and orchestrates high-quality submissions and health authority engagements across regions. The incumbent mentors regulatory strategists drive consistency and excellence, and influences external policy discussions where relevant.

Responsibilities

Own global regulatory strategies and roadmaps; align with TPP and commercial goals; Lead preparation of major submissions, scientific advice and clinical trial applications; coordinate HA meetings and responses; Guide cross-functional teams on regulatory expectations (CMC / Nonclinical / Clinical) within the company and with partners, and documentation standards; Manage risk registers and mitigation; support labeling negotiations and lifecycle planning; Develop capability within the function of coaching and standards; Manage internal and external high-level interactions with Executive Management and stakeholders; Lead the Regulatory strategy and Medical writing teams

Requirements

Advanced degree in Life Sciences/Pharmacy/Medicine; 12–15+ years in Regulatory Affairs with global submission leadership; Demonstrated experience advancing assets from early development through regulatory approval in the EU and the US; Expert knowledge of ICH and regional frameworks (US/EU/ROW); Exceptional communication, influence, and strategic thinking; Fluency in English

Nice to have

Experience in dermatology, immunology, biologics or specialty medicines; Application of digital and artificial intelligence tools; Experience in leading a team; Strategic, business-oriented and patient-centric leader able to influence senior stakeholders; Experience with expedited pathways and complex modalities; External policy/industry working group participation; Inspection/due diligence experience