Senior Associate Regulatory Writing
About this opportunity
Career Category
Regulatory
Job Description
ABOUT AMGEN
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
Roles & Responsibilities
Writes and edits non-complex regulatory documents (eg, simple clinical study report, investigator brochure, protocol, protocol amendments, Plain Language Protocol Synopsis, Plain Language Summary) and simple standalone documents (eg, informed consent forms and amendments)
Participates in collaborative team activities for non-complex documents, including support to collect input from authors/reviewers
Participates in the cross-functional document review process, comment triage, meeting attendance, and incorporation of feedback for development of subsequent drafts or for finalization
Generates appropriate in-text tables and figures
Manages the development of regulatory documents, ensuring compliance with guidelines and timelines; collaborate with Project Teams to track progress, facilitate reviews, and ensure documents meet regulatory standards for submission.
Learns and uses organizationally required authoring tools and technology platforms
Attends cross-functional meetings with other writers and departments, as appropriate, to share and gather information relevant for successful completion of their own and inter-dependent projects
Documents in scope include, but are not limited to: Clinical Study Reports, Observational Research Study Reports, Plain Language Summaries, Investigator Brochures, local Risk Management Plans, non-complex Original Protocols/ Protocol Amendments, and ICFs.
Understands and complies with SOPs, templates, best practices, policies, Regulatory Writing Style Guides
EQUAL OPPORTUNITY STATEMENT
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 with 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 an accommodation.
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Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 83 comparable Senior Regulatory Affairs roles across 41 biopharma companies.
Salary context
32 of 83 peers report a salary range (USD, annualized)
Peers share this role's job function and a matching or adjacent seniority level -- not necessarily the same therapeutic area or country.
Where these roles are based
Top locations among the 83 comparable roles
+ 15 more countries
Seniority mix
83 of 83 peers have a known seniority level
Therapeutic area mix
9 of 83 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.