Executive Director Regulatory Affairs Strategy

Job Description

Job Description

This job is posted on behalf of Clinical Dynamix, Inc. by Top Echelon.

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.

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Your Contributions (include, but are not limited to):

Strategic Regulatory Leadership

• Leads the development and execution of innovative, global regulatory strategies across early- and late-stage Endocrinology programs, including rare and obesity indications
• Integrates scientific, clinical, safety, and commercial considerations to build cohesive regulatory roadmaps from first-in-human through post-marketing lifecycle management
• Provides guidance on complex regulatory issues to cross-functional teams and senior management, ensuring broad understanding of the benefits and risks of different regulatory strategies
• Advises on translating regulatory requirements into differentiated strategy and business opportunity
• Serves as a senior regulatory voice in discussions involving safety signals, benefit-risk assessment, and strategic response planning

Cross-Functional Influence & Commercial Value Creation

• Partners closely with Clinical Development, Safety, Commercial, CMC, Quality, and Legal to ensure aligned and value-generating regulatory strategies
• Operates as a strategic thought partner to senior leaders, contributing to high-level portfolio and commercial decision-making
• Builds consensus by presenting compelling, data-driven cases for strategic direction, negotiating persuasively, and addressing disagreements constructively
• Coaches teams in making timely, high-quality decisions that appropriately balance uncertainty with the need for decisive action

People Leadership & Organizational Development

• Leads and develops a team of three regulatory strategists, fostering accountability, growth, and high performance
• Demonstrates a consistent record of developing talent through informal mentorship and direct supervisory relationships
• Cultivates a workforce through hiring, promotion, and staff development aligned with current and emerging talent needs
• Champions ethical professional behavior and creates conditions for a productive, respectful, and inclusive work environment

Governance & Compliance

• Ensures compliance with global regulatory requirements across assigned programs
• Guides teams in navigating regulatory ambiguity while maintaining the highest standards of integrity and compliance
• Contributes to broader regulatory leadership initiatives and enterprise governance forums as needed

Requirements:

Typical Experience or Education

• BS/BA degree in a life science AND BS/BA degree and 17+ years relevant biopharma and/or regulatory experience including previous leadership experience OR
• Master's degree preferred AND 15+ years of related experience as note above OR
• PhD AND 12+ years of related experience

Common Knowledge & Skills

• Proven leadership abilities, including the ability to influence across functions & levels in an organization; skilled diplomat
• 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

Job Specific Knowledge & Qualifications

• 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