Looking for pharma jobs or pharmaceutical careers in India? Apply for the Senior Associate Regulatory Writing role at Amgen in Hyderabad – a full-time on-site opportunity in regulatory documentation. Requisition ID R-255889
Amgen – Job Details
- Company: Amgen – Global biotechnology pioneer
- Location: India – Hyderabad
- Role: Senior Associate Regulatory Writing
- Department: Regulatory
- Work Type: Full time, On Site
- Job ID: R-255889
Job Description
Amgen is hiring Senior Associate Regulatory Writing professional in Hyderabad to support development of high-quality regulatory documents. Focus on writing, editing, managing non-complex regulatory materials for clinical studies while ensuring compliance with guidelines, SOPs, and submission standards. Ideal for candidates with strong scientific writing skills.
Skills / Qualifications
- Ability to write and edit non-complex regulatory documents accurately
- Strong attention to detail and organizational skills
- Experience participating in collaborative cross-functional document reviews
- Ability to generate in-text tables and figures
- Familiarity with regulatory guidelines, SOPs, templates, style guides
- Proficiency in organizationally required authoring tools and technology platforms
- Strong communication skills for cross-functional meetings and feedback incorporation
- Ability to manage document development timelines and track progress
- Understanding of clinical study reports (CSR), investigator brochures (IB), protocols, informed consent forms (ICF)
Key Responsibilities
- Write and edit non-complex regulatory documents such as CSRs and protocols
- Prepare investigator brochures, protocol amendments, plain language summaries
- Draft simple standalone documents including informed consent forms
- Participate in collaborative team activities and collect author/reviewer input
- Support cross-functional document review, comment triage, feedback incorporation
- Generate appropriate in-text tables and figures
- Manage regulatory document development to meet guidelines and timelines
- Collaborate with project teams to track progress and ensure submission readiness
- Learn and use required authoring tools and technology platforms
- Comply with SOPs, templates, best practices, policies, style guides
Benefits / Perks
- Career growth within leading global biotechnology company
- Learning opportunities in regulatory writing and document management
- Collaborative innovation-driven work culture
- Exposure to global regulatory standards and clinical documentation
- Contribute to innovative medicines that improve patients’ lives
How To Apply – Verified Post
Verification: View original announcement on Amgen career page.
🔗 Click below to apply directly for this job
Apply online via official Amgen careers portal using requisition ID R-255889. Search for “Senior Associate Regulatory Writing” and submit application.
Tags: Amgen Hyderabad Senior Associate Regulatory Writing Jobs, R-255889 Full Time On Site, CSR Protocol IB ICF Regulatory Documentation, Regulatory Guidelines SOP Templates, Amgen Careers Hyderabad Biotechnology
