New · posted Nov 8
Amgen · Biotechnology
Regulatory Affairs Manager - CMC
- 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
Associate’s 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
- Degree in a life sciences discipline, or equivalent relevant experience.
- Experience in Regulatory CMC within the pharmaceutical or biotechnology industry.
- Working knowledge of ICH guidelines and current GMP and GCP requirements.
- Experience preparing and compiling regulatory dossiers in accordance with ICH guidelines and Common Technical Document (CTD) structure.
- Experience in pharmaceutical or biotechnology manufacturing, Quality Control (QC), or Quality Assurance (QA).
What you'll do
Let’s do this. Let’s change the world. In this vital role you will be responsible for the strategy and execution of the site-specific aspects of the preparation of CMC post-market supplements and facility registrations. You will interface with site functions to coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity and provide impact assessments for deviation with input from the CMC Product teams and the CMC Region representative.
You will serve as Regulatory CMC voice for product teams by providing the following services:
- Define minimum regulatory filing requirements for post approval programs
- Provide regulatory strategy through development of MASP and/or GIRS
- Development of post approval variations
- Maintenance of applications (Annual Reports, Distribution Reports, Annual Stability updates)
- Maintain product compliance through appropriate regulatory filings and activities including regulatory commitments
- Provide impact assessments for deviation with input from the CMC Product teams and the CMC Region representative
- Support Change Management activities as needed
- Respond to regulatory agency questions
- Facilitate agency interactions, including meeting preparation, meetings and briefing documents
- Liaise with other Functions in development, operations, and commercial to ensure alignment of global regulatory strategies, timing, execution and plans
- Contribute to the PDT’s Variation Master Plan as required
- Participate as an active member of cross-functional teams
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 13% below the US median for Regulatory CMC roles at this level.
This roleEmployer provided
Manager roles in the US18 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $113,000 | — | $153,000 |
| All US (middle half) | $142,000 | $152,250 | $164,000 |
This role: Amgen's own published range. Comparisons: the base pay employers published on open Regulatory CMC roles at the same level on Regulatory Jobs, November 8, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory CMC
The general path across 89 open Regulatory CMC 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 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership6
- Regulatory submissions5
- Documentation and SOPs3
- GMP and compliance2
- Investigations and CAPA2
- Lab testing and methods1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory CMC work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- ICHICH Q11(official source, opens in a new tab)Development and manufacture of drug substances
- ICHICH Q12(official source, opens in a new tab)Lifecycle management of post-approval chemistry, manufacturing and controls changes
- 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
- ICHICH Q1 stability testing(official source, opens in a new tab)Stability testing of drug substances and drug products
- ICHICH Q5 and Q6B(official source, opens in a new tab)Quality of biotechnological products and their specifications
- FDAFDA eCTD(official source, opens in a new tab)The electronic Common Technical Document format for drug and biologic submissions
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- ICHICH Q3 impurities(official source, opens in a new tab)Impurities in drug substances and products, residual solvents and elemental impurities
- ICHICH M7(official source, opens in a new tab)Assessment and control of mutagenic impurities
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
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 - CMC at Amgen
Applications close November 13. $113K–$153K a year, employer provided.