Executive Director Regulatory Affairs Strategy

About the Role:The Executive Director, Regulatory Strategy - Endocrinology is a senior regulatory leader responsible for shaping and driving global regulatory strategy across Company's Endocrinology pipeline, spanning early development through commercialization. This leader will oversee regulatory strategy for programs in rare endocrine disorders and obesity and will directly lead a team of three regulatory professionals.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. The Executive Director will serve as a key voice at senior leadership tables, influencing cross-functional decisions to optimize regulatory pathways, accelerate development timelines, and enhance long-term commercial value.Your Contributions (include, but are not limited to):Strategic Regulatory LeadershipLeads the development and execution of innovative, global regulatory strategies across early- and late-stage Endocrinology programs, including rare and obesity indicationsIntegrates scientific, clinical, safety, and commercial considerations to build cohesive regulatory roadmaps from first-in-human through post-marketing lifecycle managementProvides guidance on complex regulatory issues to cross-functional teams and senior management, ensuring broad understanding of the benefits and risks of different regulatory strategiesAdvises on translating regulatory requirements into differentiated strategy and business opportunityServes as a senior regulatory voice in discussions involving safety signals, benefit-risk assessment, and strategic response planningCross-Functional Influence & Commercial Value CreationPartners closely with Clinical Development, Safety, Commercial, CMC, Quality, and Legal to ensure aligned and value-generating regulatory strategiesOperates as a strategic thought partner to senior leaders, contributing to high-level portfolio and commercial decision-makingBuilds consensus by presenting compelling, data-driven cases for strategic direction, negotiating persuasively, and addressing disagreements constructivelyCoaches teams in making timely, high-quality decisions that appropriately balance uncertainty with the need for decisive actionPeople Leadership & Organizational DevelopmentLeads and develops a team of three regulatory strategists, fostering accountability, growth, and high performanceDemonstrates a consistent record of developing talent through informal mentorship and direct supervisory relationshipsCultivates a workforce through hiring, promotion, and staff development aligned with current and emerging talent needsChampions ethical professional behavior and creates conditions for a productive, respectful, and inclusive work environmentGovernance & ComplianceEnsures compliance with global regulatory requirements across assigned programsGuides teams in navigating regulatory ambiguity while maintaining the highest standards of integrity and complianceContributes to broader regulatory leadership initiatives and enterprise governance forums as neededRequirements:Typical Experience or EducationBS/BA degree in a life science AND BS/BA degree and 17+ years relevant biopharma and/or regulatory experience including previous leadership experience ORMaster's degree preferred AND 15+ years of related experience as note above ORPhD AND 12+ years of related experienceCommon Knowledge & SkillsProven leadership abilities, including the ability to influence across functions & levels in an organization; skilled diplomatDemonstrated ability to build consensus by presenting a compelling case for ideas, negotiating persuasively, and addressing disagreements constructivelySuccessfully manages ambiguity & uncertainty in decision-makingTrack record of successfully leveraging relationships with other companies, trade associations, and government-industry coalitions to advance an organization's interestsDemonstrated record of developing talent through informal mentorship and direct supervisory relationshipsCultivates a workforce through hiring, promotion, and staff development that is well-aligned with current and emerging talent needsChampions ethical professional behavior; creates conditions for a productive and respectful work environmentExceptional interpersonal, problem-solving, analytical, and organizational skills, possessing an ethos of accountabilityEnsures compliance with regulatory requirementsJob Specific Knowledge & QualificationsExtensive experience developing regulatory strategy across early and commercial stages of developmentExperience supporting or maintaining commercial products, with strong understanding of lifecycle management and post-marketing regulatory strategyDeep understanding of regulatory strategy within rare disease and/or obesity markets strongly preferredAbility to synthesize scientific, clinical, safety, and business inputs into cohesive regulatory strategyExperience across diverse therapeutic modalities (e.g., antibodies, peptides, small molecules) is preferredStrong presentation and communication skills, with the ability to convey complex regulatory strategy to audiences of varying sophisticationDemonstrated expertise in FDA regulatory frameworks and evolving regulatory policy landscape