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 cutting-edge 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.

Key Responsibilities:
• Independently author routine to moderately complex regulatory documents, including: ICFs and ICF Amendments, PLPSs and PLPS Amendments, CSR sections (synoptic, abbreviated, and standard reports; pivotal CSRs with guidance/support), PLS, Protocol Amendments and Country-Specific Protocol Supplements, IB updates (minor/focused updates).
• Manage document versions, reviewer comments, and approval workflows end-to-end for assigned documents.
• Ensure assigned documents are scientifically accurate, internally consistent, and aligned with source data and program objectives.




• Prepare documents that are QC-ready and inspection-ready, adhering to applicable guidance documents, SOPs, and regulatory requirements.
• Support audits and inspections by providing document history, supporting documentation, and justification/rationale as required.
• Collaborate with Clinical, Safety, Regulatory, and Study teams to clarify inputs, resolve comments, and efficiently incorporate feedback.
• Participate in document-related meetings, as required.
• Proactively escalate risks, scope changes, and timeline challenges to managers.
• Track assigned deliverables and ensure adherence to agreed timelines.
• Participate in internal training programs, knowledge-transfer sessions, and continuous process improvement initiatives.
• Demonstrate consistent, on-time delivery of assigned deliverables.

Collaboration Skills
• Cross-functional stakeholder management
• Effective communication and present

📌 Global Regulatory Writing – Senior Associate (Hyderabad)
🏢 AMGEN
📍 Hyderabad