• Develop and lead global regulatory strategies for small-molecule and biologic programs supporting clinical development across oncology and autoimmune indications, from early-stage studies through registration
• Oversee all regulatory submission activities, including planning, authoring, review, coordination, and delivery of documents for Pre-IND, IND, and marketing applications (NDA/BLA), as well as other lifecycle submissions
• Ensure timely preparation of high-quality regulatory documentation and dossiers
• Lead interactions with regulatory authorities, including setting meeting objectives, preparing briefing materials, coordinating internal rehearsals, and managing risk-mitigation plans
• Collaborate closely with cross-functional teams to integrate regulatory considerations into program plans and ensure alignment with overall development timelines and objectives
• Present and defend regulatory strategies in project team meetings and with external partners
• Work with internal functions to ensure compliance with regulatory standards and support audit/inspection readiness
• Maintain up-to-date knowledge of relevant regulatory guidelines, global requirements, and the evolving competitive landscape

Provide support across additional regulatory or program activities as needed

• Strong understanding of FDA, EMA, and ICH regulations, with demonstrated proficiency in regulatory submissions and approval processes
• Proven track record of achieving regulatory milestones throughout development and registration phases
• Experience leading communications and negotiations with regulatory agencies
• Ability to guide cross-functional teams and collaborate effectively with CRO partners
• Exceptional attention to detail and adherence to established procedures
• Highly organized, self-directed, and able to work effectively within a collaborative environment
• Strong decision-making skills and the ability to think creatively while upholding regulatory and quality standards
• Skilled in identifying and communicating critical issues to senior management
• Capable of managing conflict and fostering productive relationships with internal and external stakeholders
• Strong sense of ownership for program success and flexibility in supporting evolving needs

Willingness to work flexible hours, including occasional calls with teams in other time zones

• Competitive salary ($150-200k)
• Professional development and potential for upward career growth

Impact in shaping regulatory strategy