Senior International Regulatory Affairs Director

Overview

In this role you lead the International regulatory strategy for high-complexity cell therapy programs, embedding region-specific needs to shape evidence, submissions, and labeling for faster patient access. You will partner with Global Product, Regulatory, Commercial, Medical, and policy teams to translate science into timely approvals across priority markets. You’ll guide pivotal decisions, mitigate risks, and position therapies for long-term success in a dynamic regulatory landscape. This role offers impact across development, launch, and lifecycle management with a strategic, cross-functional focus.

Pay / Benefits

• hybrid work model with a minimum of three days in the office
• flexible working arrangements
• inclusive and supportive culture
• adjustments/accommodations available for candidates
• opportunity to shape cutting-edge therapies

Responsibilities

• Own the International strategy for complex cell therapy programs with embedded regional requirements
• Lead end-to-end international strategy from development through major submissions, approval, launch and lifecycle management
• Integrate clinical, CMC, safety, quality, commercial and medical considerations to shape evidence generation and decision-making
• Orchestrate international Health Authority engagements and advisory preparations; brief senior leaders on scenarios and implications
• Direct international dossier planning, labeling and negotiation readiness; ensure timely, high-quality submissions
• Collaborate with senior Area Regulatory Directors and country leads to anticipate market needs and align clinical/regulatory plans
• Continuously assess emerging data against approvability and patient value; lead decision-making under uncertainty
• Lead the International Regulatory Team, providing coaching and performance feedback
• Champion innovative regulatory strategies and policy initiatives to advance access to cell therapies

Key requirements

• Strong international regulatory experience with senior accountability in drug, biologic or cell therapy development
• Proven success in cell therapy regulatory strategy for high-profile or novel programs
• Extensive knowledge of global regulatory science and CGT/biologic CMC regulations
• Experience with regulatory filings (IND, IMPD, BLA, MAA) and associated CMC components
• Leadership of at least one major global or international regulatory approval, including labeling negotiations
• Experience leading health authority interactions in major markets and preparing cross-functional teams for critical engagements
• Broad pharma background across Global/European/International/Marketing Company or Health Authority settings
• Experience with ex vivo and in vivo cell therapies and related therapeutic areas (oncology, autoimmunity, rare diseases)
• Strong program management and stakeholder management skills
• Strong commercial awareness linking regulatory strategy to product value and patient access
• Credibility to advise networks on regulatory science questions

• Cross-cultural effectiveness
• Influencing and negotiation
• Communication (clear, concise, targeted)
• Global regulatory systems knowledge (CGTs, biologics)
• CMC regulations for CGTs and biologics
• IND/IMPD/BLA/MAA filings and lifecycle management

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