Seniorr Associate Regulatory Writing
Amgen · Hyderabad
- Experience2–7 yrs
- SalaryNot disclosed
- Work modeonsite
- Levelmid
- Posted16 Sept 2026
About Amgen
Amgen is hiring in Hyderabad in pharma biotech. This role looks for around 2+ years of experience.
Skills
- regulatory writing
- clinical research
- document control
- inspection readiness
- SharePoint
- RIM tools
- authoring platforms
- project management
- risk mitigation
The role
A regulatory writer at a biotechnology medicines company authors clinical documents using regulatory writing and clinical research, manages document control and inspection readiness, and coordinates cross-functional reviews with Clinical, Safety, and Regulatory teams using SharePoint.
Full job description
India - Hyderabad
JOB ID: R-255150 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Sep. 16, 2026 CATEGORY: Regulatory
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.