We are seeking an Executive Director, Regulatory Strategy to lead the development and execution of global regulatory strategies across our Endocrinology pipeline. This role requires a highly strategic, scientifically grounded, and commercially savvy regulatory executive who can integrate complex development considerations, safety signals, and evolving regulatory requirements into clear, value-maximizing strategies.
Requirements
- BS/BA degree in a life science AND BS/BA degree and 17+ years relevant biopharma and/or regulatory experience including previous leadership experience
- Master's degree preferred AND 15+ years of related experience
- PhD AND 12+ years of related experience
- Proven leadership abilities, including the ability to influence across functions & levels in an organization
- Demonstrated ability to build consensus by presenting a compelling case for ideas, negotiating persuasively, and addressing disagreements constructively
- Successfully manages ambiguity & uncertainty in decision-making
- Track record of successfully leveraging relationships with other companies, trade associations, and government-industry coalitions to advance an organization’s interests
- Demonstrated record of developing talent through informal mentorship and direct supervisory relationships
- Cultivates a workforce through hiring, promotion, and staff development that is well-aligned with current and emerging talent needs
- Champions ethical professional behavior; creates conditions for a productive and respectful work environment
- Exceptional interpersonal, problem-solving, analytical, and organizational skills, possessing an ethos of accountability
- Ensures compliance with regulatory requirements
- Extensive experience developing regulatory strategy across early and commercial stages of development
- Experience supporting or maintaining commercial products, with strong understanding of lifecycle management and post-marketing regulatory strategy
- Deep understanding of regulatory strategy within rare disease and/or obesity markets strongly preferred
- Ability to synthesize scientific, clinical, safety, and business inputs into cohesive regulatory strategy
- Experience across diverse therapeutic modalities (e.g., antibodies, peptides, small molecules) is preferred
- Strong presentation and communication skills, with the ability to convey complex regulatory strategy to audiences of varying sophistication
- Demonstrated expertise in FDA regulatory frameworks and evolving regulatory policy landscape
Benefits
- Retirement savings plan (with company match)
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits to include medical, prescription drug, dental and vision coverage
