Job Title:
Associate Regulatory Writing
Job Details:
Job ID: R-224167
Location: India – Hyderabad
Work Type: On-site
Date Posted: August 29, 2025
Category: Regulatory
Company: Amgen
About Amgen:
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases and improve patients’ lives. With over 40 years of biotechnology innovation, Amgen continues to lead with cutting-edge science and human genetic data to develop and deliver life-changing medicines globally.
Roles & Responsibilities:
Prepare clinical regulatory documents for public disclosure, including:
Anonymization of personal data
Redaction of commercially confidential information
Ensure consistent quality across documents, maintain submission readiness, and ensure timely submission or posting
Collaborate with team members to resolve problems and escalate issues as needed
Record and maintain written redaction strategies for studies and products
Manage timelines and coordinate work across the team
Execute clinical trial disclosure processes ensuring compliance with:
Regulatory requirements
Amgen policies
SOPs and guidance documents
Act as tactical point of contact for assigned responsibilities, complete assigned action items, and maintain documentation
Assist and support clinical trial disclosure audits and inspections
Serve as Process Administrator for the Clinical Trial Registry System (CTRS):
Support active users, manage system access, handle inquiries, and resolve issues
Generate and manage reports, trackers, portals, and metrics activities
Required Skills:
Ability to understand and interpret data/information and apply it practically
Self-motivated with strong multitasking, attention to detail, and follow-through
Ability to follow controlled processes
Excellent spoken and written English communication skills
Project management skills, including the ability to prioritize work to meet deadlines
Strong problem-solving ability
Basic Qualifications:
Bachelor’s degree
Minimum 1 year experience working with regulatory documents in a biotech/pharmaceutical environment
Familiarity with clinical research and clinical regulatory documents
Knowledge of clinical trial disclosure regulations, guidelines, and best practices
Preferred Qualifications:
Over 1 year experience preparing regulatory documents for public disclosure
Familiarity with Clinical Trial Registry System, NIH Protocol Registration System (PRS), ClinicalTrials.gov, EudraCT, EU CTIS, and other registries
Experience with redaction/anonymization of clinical trial documents
Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer and considers applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Reasonable accommodations are provided to individuals with disabilities throughout the hiring process and employment. Please contact Amgen to request accommodations.
Apply Now
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