Global Regulatory Director Lead

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Global Regulatory Director Lead in the United States.

We are seeking an experienced Global Regulatory Director Lead to provide strategic oversight and direction for programs focused on obesity and related cardiometabolic conditions. In this role, you will develop and execute global regulatory strategies, lead interactions with health authorities, and advise cross-functional teams on clinical, scientific, and regulatory matters. You will ensure that regulatory approaches are scientifically robust, compliant, and aligned with corporate goals while guiding complex global submissions. This position offers the opportunity to influence innovative therapeutic programs, mentor regulatory teams, and collaborate with internal and external stakeholders across multiple geographies. The ideal candidate combines scientific literacy in metabolic disorders with proven regulatory leadership experience in a fast-paced, global environment.

Accountabilities:

Develop and lead global regulatory strategies for obesity, Type II diabetes, and related cardiometabolic programs.
Integrate clinical, nonclinical, CMC, and safety data into cohesive regulatory recommendations and strategic plans.
Oversee major global submissions, including clinical trial applications, marketing applications, pediatric plans, and labeling updates.
Lead regulatory interactions with health authorities (FDA, EMA, PMDA, NMPA) and external scientific alliances.
Collaborate cross-functionally with Clinical Development, Safety, CMC, Commercial, and regional regulatory colleagues to ensure strategic alignment.
Build, mentor, and guide high-performing regulatory teams, fostering an inclusive, collaborative environment.
Translate complex metabolic science into actionable regulatory guidance and decision-making frameworks.

Requirements:

Doctorate degree with 4+ years regulatory experience, or Master’s with 7+ years, or Bachelor’s with 9+ years.
8–10+ years of global regulatory experience, preferably in obesity, Type II diabetes, metabolic disorders, endocrinology, or cardiovascular risk programs.
Strong scientific knowledge in metabolic biology, adiposity physiology, endocrine pathways, and associated clinical endpoints.
Demonstrated experience developing global submissions and leading interactions with FDA, EMA, and other regulatory bodies.
Proven leadership in managing global regulatory teams and influencing governance bodies.
Excellent communication, negotiation, and problem-solving skills; ability to manage high-stakes, complex regulatory decisions.
Experience with real-world evidence, long-term outcome measures, and chronic disease regulatory considerations is a plus.

Benefits:

Competitive base salary and discretionary annual bonus.
Comprehensive health, dental, and vision insurance.
Stock-based long-term incentives and retirement savings plans.
Generous time-off policies and flexible work models where applicable.
Professional development opportunities and career growth in a collaborative environment.
Chance to work on innovative programs impacting patient health globally.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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Global Regulatory Director Lead

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