Career CategoryRegulatory
Job DescriptionExecutive Director of Regulatory Affairs & Obesity Related ConditionsWhat you will doLet's do this. Let's change the world. In this vital role as Executive Director of Regulatory Affairs, you will direct regulatory affairs activities within an assigned disease area, ensuring compliance with applicable laws and regulations. You will also provide strategic direction and leadership to the regulatory affairs team.
The Executive Director of Regulatory Affairs is a product facing cross-indication regulatory integration role that leads a designated part of the Obesity and Related Conditions Global Regulatory Therapeutic Area in the Global Regulatory Affairs organization. This role ensures strategic coherence, alignment, and risk management across multiple products with concurrent indications and global filings.
This role will report into the Vice President, Global Regulatory Affairs.
Responsibilities:- Lead, coach, and mentor staff to develop a high-performing regulatory organization grounded in continuous learning, with a strong focus on talent development, leadership capability, and a succession planning culture.
- Build strong alignment across global and regional teams ensuring clarity of purpose, priorities and coordinated execution
- Guide integrated cross-indication regulatory strategy across Obesity programs, ensuring alignment of development pathways, evidence generation, and global registration approaches
- Provide strategic regulatory expertise and guidance to therapeutic area commercialization teams and other governance bodies
- Act as a trusted strategic partner to Global Regulatory Leaders (GRLs) providing guidance on complex regulatory decisions, risk management, and long-term strategy
- Conduct management review and approval of Global Regulatory Strategic Plans
- Conduct review and approval of key documents for regulatory submissions
- Anticipate and translate the evolving regulatory landscape within therapeutic area into forward looking regulatory strategies and opportunities
- Work externally to influence regulatory legislative environment in line with Amgen policy priorities for the therapeutic area
- Oversee and participate in licensing/acquisition due diligence and other activities in partnership with Amgen licensing groups
- Communicate and ensure alignment of global functional and cross-functional goals and objectives
Knowledge and skills include:- Demonstrated experience leading complex, multi-indication regulatory strategy integration
- Demonstrated ability to lead teams
- Strong communication skills - both oral and written
- Ability to understand and communicate scientific information
- Comprehensive understanding of regulatory activities and how they affect projects and processes
- Demonstrable ability to set organizational direction & champion change and continuous improvement
- Proven ability to anticipate and mitigate against future strategic issues & uncertainties
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Proven ability to drive enterprise-level alignment under high portfolio complexity
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The executive candidate we seek is an experienced leader with the following qualifications.
Basic Qualifications:- Doctorate degree & 6 years of regulatory affairs experience OR
- Master's degree & 10 years of regulatory affairs experience OR
- Bachelor's degree & 12 years of regulatory affairs experience AND
- 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications:- Demonstrated leadership of regulatory strategy for programs in obesity, metabolic disorders, endocrinology, cardiovascular risk, or related therapeutic areas.
They will also embody the Amgen leadership attributes which are:
- Inspire: Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
- Accelerate: Enable speed that matches the urgency of patient needs by encouraging progress over perfection
- Integrate: Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
- Adapt: Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is $255,302 - $345,408. Actual salary will vary based on several factors including, but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range255,301.75USD -345,408.25 USD
