New · posted Oct 30
Amgen · Biotechnology
Regulatory Policy and Intelligence Associate Director
- Remote, US
- Remote
- Full-time
- Director
What you need
Two ways to qualify
PhD
+ 10 years of experience
Doctorate or Master’s degree (scientific area) and 10 years of directly related regulatory policy experience, including FDA and international regulators.
- or
Bachelor’s
+ 12 years of experience
Bachelor’s degree (scientific area) and 12 years of directly related experience.
Basic Qualifications
Doctorate degree or 3 years of regulatory experience
OR
Master’s degree and 5 years of related experience
OR
Bachelor’s degree and 7 years of regulatory experience
OR
Associate’s degree and 12 years of regulatory experience
OR
High school diploma / GED and 14 years of regulatory experience
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Preferred Qualificationsnice to have
- In-depth knowledge and demonstrated policy leadership with U.S. legislation and regulations relating to medicinal products.
- Trade association or consortia experience.
- A strong team player with a demonstrated track record of working collaboratively across functional areas.
- Strong oral and written communication skills.
- Strong interpersonal, problem solving, and conflict resolution skills.
- Demonstrated capacity to work well with people at all levels of the organizing in demanding situations with a positive attitude, tact, diplomacy, and respect.
- Demonstrated ability to work in a fact-paced environment with retaining a high attention to detail and quality.
- Excellent organization, process, and project management skills.
- undefined
What you'll do
Let’s do this. Let’s change the world. The Regulatory Policy and Intelligence team advances important policy issues, aligned with Amgen’s goals and priorities, by engaging externally with regulators, industry trade associations, consortia and other stakeholders, along with internal subject matter experts across Amgen. In this vital role, you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business within a defined portfolio, exercising independent judgement and driving cross-functional alignment. You will report to the Amgen’s U.S. Lead for Regulatory Policy and Intelligence.
- Foster U.S. trade association relationships and provide stewardship over the company’s regulatory and R&D-related trade association engagements.
- Staff company executives in leadership roles in domestic and international forums.
- Develop and lead enterprise-wide regulatory reform initiatives; implement strategies to shape policy outcomes, the external environment and identify related internal business needs for implementation.
- Lead assigned policy initiatives from analysis and position development through external engagement and implementation, in partnership with policy leads and management.
- Partner with policy leads and subject matter experts, including Government Affairs, R&D, Operations, and other relevant stakeholders, to develop advocacy materials on priority policy issues.
- Prepare presentations and other communications to support alignment on positions and strategies across the Amgen organizations and regions.
- Investigate policy research questions on key policy topics and determine the implications of emerging regulatory developments.
- Analyze regulatory guidances and other regulatory policy documents to inform positions and impact assessments.
- Plan and help manage projects for agreed upon policy objectives under the direction of and in partnership with policy lead(s) and management.
Pay and benefits
$155,000 – $210,000 a year
Employer providedUSD - USD
What you can expect of us
A 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
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
As 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 $155,365 - $210,199. 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:
Working conditions
Career Category
Regulatory
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
From the posting
About Amgen
Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Equal opportunity, accessibility and legal noticesAmgen's statements, word for word
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, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Job intelligence
The context around this role
Live data · October 31, 2026
Salary intelligence
How the pay compares
This role's midpoint is 22% below the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Director roles in the US95 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $155,000 | — | $210,000 |
| All US (middle half) | $206,750 | $235,000 | $264,000 |
This role: Amgen's own published range. Comparisons: the base pay employers published on open Regulatory Affairs roles at the same level on Regulatory Jobs, October 31, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 303 open Regulatory Affairs roles on Regulatory Jobs, with the titles they carry most. Not Amgen's own promotion track.
Career resources on Regulatory Affairs
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership11
- Documentation and SOPs3
- GMP and compliance1
- Investigations and CAPA1
Company hiring pulse
Amgen on Regulatory Jobs
- 37
- Open roles
- 35
- Distinct roles
- 5
- Locations
By discipline
- Quality25 68%
- Regulatory12 32%
By level
- Manager14 38%
- Senior & Principal13 35%
- Director5 14%
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Regulatory Policy and Intelligence Associate Director at Amgen
Open until filled. $155K–$210K a year, employer provided.