Head of Regulatory Affairs Policy & Regulatory Intelligence

8-15 yrs required

Full-time

No

Join Us

If you’re seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you’ll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.

Head of Regulatory Affairs Policy & Regulatory Intelligence - Defy Imagination, Change Lives

Are you a high-level expert in regulatory affairs looking for an opportunity to lead and forge partnerships that can change lives? Amgen, one of the world's preeminent biotechnology companies, is seeking a Head of Regulatory Affairs Policy & Regulatory Intelligence to join their team. In this role, you will be responsible for shaping Amgen's regulatory policy strategy and leading global policy and regulatory intelligence teams.

Responsibilities:

- Lead teams of policy experts and subject matter experts to accomplish policy goals
- Interpret and anticipate changes in the regulatory environment
- Communicate regulatory developments to stakeholders within Amgen
- Partner with various departments to align regulatory and R&D policy priorities
- Develop and implement advocacy strategies to influence external actions
- Monitor legislative, regulatory, and guidance developments and coordinate Amgen's review and comment on documents
- Keep abreast of Amgen's product development plans and issues

Qualifications:

- Doctorate degree with 8 years of regulatory affairs experience OR Master's degree with 10 years of experience OR Bachelor's degree with 12 years of experience
- 8 years of direct managerial experience, including managing other managers
- Advanced scientific, legal, or public health degree preferred
- 15 years of pharmaceutical industry-related experience in drug development, public health, and/or regulatory policy or law
- Demonstrated expertise as an external thought leader
- Strong written, spoken, and presentation communication skills
- Ability to establish strategic relationships with internal and external customers and partners
- Demonstrated leadership skills in areas of influence, team leadership, negotiation, and conflict resolution
- Ability to make quality decisions in a highly regulated environment
- Strong understanding of Amgen's leadership attributes: inspire, accelerate, integrate, and adapt

Salary and Benefits:

- Annual base salary range in the . is $277,673 - $339,378
- Comprehensive employee benefits package, including retirement and savings plan, medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts
- Discretionary annual bonus program or sales-based incentive plan for field sales representatives
- Stock-based long-term incentives
- Award-winning time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements
- Commitment to staff well-being, including benefits for transgender employees and family-friendly offerings

Join the Amgen Team:

At Amgen, our mission is to serve patients and push the boundaries of science to transform medicine. We believe in creating a people-first environment where our staff can thrive and make significant contributions. We are an equal opportunity employer and value diversity, ethics, and commitment in our team members. If you're seeking a career with a company that fosters an inclusive and diverse environment and is dedicated to improving the quality of life for people around the world, join the Amgen team today.

Not specified

Comprehensive employee benefits package, including retirement and savings plan, medical, dental, and vision coverage, life and disability insurance, flexible spending accounts, discretionary annual bonus program, stock-based long-term incentives, award-winning time-off plans, bi-annual company-wide shutdowns, flexible work models, and accommodations for individuals with disabilities.

Not specified

Leadership, Strategic Thinking, Communication, Team Building, Risk Management, Relationship Building, Policy Development, Advocacy Strategy, Decision Making

Doctorate degree OR Master's degree OR Bachelor's degree in a relevant field

Interested candidates should apply through the Amgen careers website.

Qualification and Experience Doctorate degree OR Master's degree OR Bachelor's degree in a relevant field

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