New · posted Nov 8
Amgen · Biotechnology
Regulatory Affairs Manager - US Regulatory Lead, Rare Disease
- Remote, US
- Remote
- Full-time
- Manager
What you need
Basic Qualifications
Doctorate degree
Master’s degree and 2 years of Regulatory Affairs experience
Bachelor’s degree and 4 years of Regulatory Affairs experience
Associates degree and 8 years of Regulatory Affairs experience
High school diploma / GED and 10 years of Regulatory Affairs 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
- Master’s degree in a biology, life science, health science curriculum, or regulatory science with biology curriculum
- Regulated industry, science or clinical practice experience
- Organizational skills - detail oriented and can deal with frequent changes in product activity
What you'll do
Let’s do this. Let’s change the world. The Regulatory Affairs Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining to the company’s business. They work with federal, state, and local regulatory agencies on issues and regulations that affect the company’s products and services.
In this vital role you will be assigned to one or more Amgen products, and plan and execute the Regulatory strategies for that product(s) in their country(ies). Specific responsibilities include but are not limited to:
- Support the Global Regulatory Team (GRT) in US Regulatory Activities (e.g. IND development and submission).
- Act as the point of contact with regulatory agencies.
- Provide guidance on local mechanisms to optimize product development and regulatory approvals.
- Plan and manage local regulatory submissions in compliance with corporate standards and local regulatory requirements.
- Ensure and support local regulatory product compliance (eg, agency commitments).
- Ensure local labels are developed and maintained in line with local legislation and Amgen standards and procedures. Support and provide input into the global regulatory strategy for assigned products, including Global Regulatory Plans, labeling documents, etc.
- Assist the GRL by preparing supportive documentation for regulatory deliverables, including for example regulatory landscapes or research for the regulatory strategy and/or target product label and managing the process for responding to regulatory agency questions.
- Provide primary authorship to routine regulatory correspondence.
Pay and benefits
$113,000 – $153,000 a year
Employer provided112,744.00USD -152,536.00 USD
What you can expect from 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 posted. 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. 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. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Job intelligence
The context around this role
Live data · November 8, 2026
Salary intelligence
How the pay compares
This role's midpoint is 17% below the US median for Regulatory Strategy roles at this level.
This roleEmployer provided
Manager roles in the US22 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $113,000 | — | $153,000 |
| All US (middle half) | $145,250 | $159,750 | $181,000 |
This role: Amgen's own published range. Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 86 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not Amgen's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions5
- GMP and compliance3
- Documentation and SOPs2
- Collaboration and leadership2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trialsNamed in the posting
- FDAFDA expedited programs(official source, opens in a new tab)Fast track, breakthrough therapy, accelerated approval and priority review
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLA
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- FDA21 CFR Part 1271(official source, opens in a new tab)Human cells, tissues, and cellular and tissue-based products
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Amgen on Regulatory Jobs
- 55
- Open roles
- 55
- Distinct roles
- 5
- Locations
By discipline
- Quality31 55%
- Regulatory13 23%
- Clinical12 21%
By level
- Manager20 36%
- Senior & Principal17 30%
- Director13 23%
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Regulatory Affairs Manager - US Regulatory Lead, Rare Disease at Amgen
Applications close November 13. $113K–$153K a year, employer provided.