Overview In this role you will shape worldwide regulatory strategy to shorten time to approval across oncology, immunology and devices. You will act as the global point of contact for regulatory affairs, guiding development teams and external partners through submissions and agency interactions. You will lead cross-functional regulatory support and ensure compliant, timely marketing authorizations. You will engage with FDA, EMA and other authorities, driving strategic direction across regions. This opportunity lets you influence product development and lifecycle management within a global, mission-driven organization.
Compensation / Benefits- medical, dental, vision insurance
- retirement benefits including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus and long-term incentive
Responsibilities- Develop worldwide regulatory strategy to optimize labeling and shorten approval timelines for multiple indications
- Provide expert regulatory advice to Product Development Teams and subsidiaries across the product lifecycle
- Lead Global Regulatory Team and coordinate cross-functional regulatory support for development programs and marketed products
- Approve local registration study protocols for marketing authorization in secondary markets
- Represent the company in meetings with regulatory authorities (FDA, EMA, etc.) and prepare teams for agency discussions
- Lead cross-functional efforts to prepare for advisory committees and coordinate regional regulatory interactions
- Review and approve Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures for external release
- Act as regulatory advisor within internal committees (DRC, PDT, EDT, LEAD) and facilitate IND/CSA content review for initial trial approval
- Participate in regulatory due diligence for licensing candidate review
Key requirements- Regulatory leadership experience in drug development or regulatory affairs
- Experience leading or supporting meetings with major health authorities and regulatory filings
- Strategic thinking, independence, and ability to work with limited supervision
- Proven communication skills (verbal and written)
- Experience with cross-functional, global teams
- Proactive, clear communicator
- Influence and negotiation
- Strategic mindset
- Global regulatory strategy development
- Regulatory submissions and filings
- Regulatory communications with agencies (FDA, EMA, others)
