Executive Director, Regulatory Strategy

Main Responsibilities: Lead the development and execution of the regulatory strategy in line with the integrated development plan for late-stage clinical programs, ensuring alignment with corporate objectives and applicable global regulatory requirements. Interface with internal and external stakeholders to develop and implement cross-portfolio global regulatory strategies in line with business objectives. Serve as the primary point of contact with the FDA — including meeting requests, briefing materials, day-to-day correspondence, and responses to information requests — and direct ex-US regulatory activities with support from consultants, vendors, and partners. Lead preparation and execution of formal health authority meetings (e.g., Type B/C, End-of-Phase 2, and pre-NDA/pre-MAA meetings), including briefing documents and cross-functional rehearsals. Independently contribute to and/or oversee the planning, compilation, review, approval, and submission of regulatory documents, including initial INDs/CTAs/NDAs/MAAs and amendments or supplements, meeting packages, expedited-program and designation requests where supported by the data (e.g., Breakthrough Therapy, Fast Track), annual reports, and Investigator's Brochures. Ensure regulatory documents and submissions are accurate, complete, verifiable, and compliant with applicable FDA, ICH, and global requirements, and that regulatory databases, submission logs, and correspondence logs are maintained. Provide quality regulatory input and strategic perspective across all stages of drug development — including clinical development plans, protocol design, endpoint strategy, and evidence-generation planning — to support informed decision-making and optimize the company's regulatory approaches for product development and lifecycle management. Lead development and maintenance of the labeling strategy, partnering with Clinical Development, Medical Affairs, and Commercial to align on the evidence required to support them and to prepare the organization for labeling discussions with health authorities. Partner closely with Regulatory CMC to ensure alignment of overall development strategies and integrated, submission-ready regulatory content. Identify and assess regulatory risks associated with development programs and define approaches to mitigate them; communicate risk assessments, scenario planning, and mitigation strategies to program teams, the SVP, Regulatory Affairs, and the Executive Leadership Team, surfacing risks early with clear, well-reasoned recommendations. Directly oversee regulatory responsibilities outsourced to CROs, consultants, and vendors, ensuring quality, strategic alignment, and compliance with applicable regulations and guidelines; provide regulatory due diligence and strategic input for business development opportunities as needed. Review, write, and present guidelines and SOPs as needed to support high-quality submissions and ensure cross-functional adherence to regulatory requirements. Maintain current knowledge of applicable US and global regulations, guidance, and standards for drug development and product registration; monitor, interpret, analyze, and disseminate regulatory intelligence that may affect ongoing development. Hire, develop, and mentor regulatory professionals, fostering accountability and a culture of collaboration.

Preferred Qualifications: Advanced degree in a scientific discipline. Exact Compensation may vary based on skills, experience and location. Pay range $266,000 —$346,000 USD