New · posted Oct 19
Amgen · Biotechnology
Regulatory Writing Senior Manager
- Remote, US
- Remote
- Full-time
- Manager
Open until filled
The role
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Or
High school diploma / GED and 12 years of directly related experience
What you need
Basic Qualifications
Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related 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
- Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
- 5+years of experience in medical writing in the Biotech/Pharmaceutical industry
What you'll do
Let’s do this. Let’s change the world. In this key role you will serve as the functional area lead on product teams, lead writing activities for complex product submissions, provide functional area expertise, train and mentor more junior writers, and lead departmental activities. Key responsibilities include:
- Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
- Conduct the formal review and approval of authored documents, following applicable standard operating procedures
- With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
- Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
- Provide functional area input for Global Regulatory Plan and team goals
- Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
- Lead departmental and cross-departmental initiatives, as appropriate
- Generate document timelines
Pay and benefits
$140,000 – $189,000 a year
Employer provided139,581.90USD -188,846.10 USD
What you can expect of us
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, including remote work arrangements, where possible
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising 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 including:
Working conditions
Career Category
Regulatory
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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.
Equal opportunity, accessibility and legal noticesAmgen's statements, word for word
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.
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 20, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% above the US median for Regulatory Affairs roles at this level.
This roleEmployer provided
Manager roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $140,000 | — | $189,000 |
| All US (middle half) | $147,500 | $162,500 | $175,000 |
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 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Affairs
The general path across 302 open Regulatory Affairs 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 18 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership8
- Documentation and SOPs7
- Regulatory submissions3
- Lab testing and methods1
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDAFDA BLA(official source, opens in a new tab)Biologics License Applications
- FDAeCTD(official source, opens in a new tab)The electronic Common Technical Document format for submissions
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Amgen on Regulatory Jobs
- 32
- Open roles
- 30
- Distinct roles
- 6
- Locations
By discipline
- Quality22 69%
- Regulatory8 25%
- Compliance & Safety2 6%
By level
- Manager13 41%
- Senior & Principal10 31%
- Associate & Specialist6 19%
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Regulatory Writing Senior Manager at Amgen
Open until filled. $140K–$189K a year, employer provided.