Executive Director of Regulatory Affairs - Obesity and Related Conditions

Executive Director of Regulatory Affairs & Obesity Related Conditions

What You Will Do
- Direct regulatory affairs activities within the Obesity and Related Conditions disease area, ensuring compliance with applicable laws and regulations.
- Provide strategic direction and leadership to the regulatory affairs team and drive cross-indication regulatory integration across multiple products and global filings.

Responsibilities:
- Lead, coach, and mentor staff; build a high-performing organization focused on talent development and succession planning.
- Align global and regional teams on purpose, priorities, and coordinated execution.
- Guide integrated cross-indication regulatory strategy across Obesity programs (development pathways, evidence generation, global registration).
- Provide strategic regulatory expertise to commercialization teams and governance bodies.
- Advise Global Regulatory Leaders on complex regulatory decisions, risk management, and long-term strategy.
- Conduct management review/approval of Global Regulatory Strategic Plans.
- Review/approve key documents for regulatory submissions.
- Anticipate and translate the evolving regulatory landscape into forward-looking strategies and opportunities.
- Influence the regulatory legislative environment in line with Amgen policy priorities.
- Oversee/participate in licensing/acquisition due diligence with licensing groups.
- Communicate and ensure alignment of global functional and cross-functional goals.

Basic Qualifications:
- Doctorate degree + 6 years regulatory affairs OR Master’s + 10 years OR Bachelor’s + 12 years; AND 6 years managerial experience directly managing people and/or leadership experience leading teams/projects/programs or directing resource allocation.

Preferred Qualifications:
- Leadership of regulatory strategy for obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas.