Seniorr 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
Independently author routine to moderately complex documents, including: ICFs and ICF amendments
PLPS and Amendments
Sections of CSRs (synoptic, abbreviated and standard; pivotal CSRs with support)
Protocol Amendments and Country Specific Protocol Supplement
IB updates (minor / focused updates)
Manage document versions, reviewer comments, and approval flows end to end for assigned documents.
Ensure assigned documents are scientifically accurate, consistent across sections and aligned with source data and program intent
Prepare documents to be QC and inspection ready, adhering to Guidance documents/SOPs
Support audits or inspections by providing documentation history and rationale when needed.
Engage with Clinical, Safety, Regulatory and Study teams to clarify inputs, resolve comments and incorporate feedback efficiently
Participate in document related meetings as required.
Escalate risks, scope changes, or timeline pressures early to Managers.
Track assigned deliverables and timelines.
Participate in internal trainings, KT sessions, and process improvements.
Consistent on time delivery
Collaboration Skills:
Cross-functional stakeholder management
Communication and presentation skills
Negotiation and conflict resolution
Strategic thinking and decision making
Ownership and accountability
. Project Management & Operational Skills
Timeline planning and execution
Managing multiple deliverables simultaneously
Risk identification and mitigation
Review coordination and comment resolution
Working effectively with document management systems, RIM tools, SharePoint, and authoring platforms
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 155 comparable Associate Regulatory Affairs roles across 63 biopharma companies.
Salary context
35 of 155 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 155 comparable roles
+ 23 more countries
Seniority mix
155 of 155 peers have a known seniority level
Therapeutic area mix
10 of 155 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.