Job Opportunity at Amgen
Position: Regulatory Associate (Clinical Trial Disclosure)
Location: India – Hyderabad
Work Location Type: On-site
Job ID: R-224183
Date Posted: August 29, 2025
Category: Regulatory
About Amgen
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, making people’s lives easier, fuller, and longer. For more than 40 years, Amgen has been a pioneer in biotechnology, developing, manufacturing, and delivering innovative medicines that help millions of patients worldwide.
Key Responsibilities
Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information, in line with regulatory requirements and agreed strategy.
Ensure consistent document quality, submission readiness, and timely handoff for submission or posting.
Collaborate across teams to resolve issues, escalate challenges when needed, and document redaction strategies.
Manage timelines and coordinate tasks within the disclosure team.
Execute clinical trial disclosure processes, ensuring compliance with regulations, Amgen policies, SOPs, and guidance documents.
Act as a tactical point of contact for assigned responsibilities, completing action items and maintaining proper documentation.
Support trial disclosure audits and inspections.
Serve as Process Administrator for the Clinical Trial Registry System (CTRS), including user support, access management, inquiries, and issue resolution.
Generate and manage reports, trackers, portals, and metrics.
Required Skills
Strong ability to interpret and apply data/information.
High attention to detail, multitasking, and follow-through.
Ability to follow controlled processes.
Strong spoken and written English communication skills.
Project management skills with the ability to prioritize to meet deadlines.
Problem-solving capability.
Basic Qualifications
Bachelor’s degree.
Minimum 1 year of 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 of experience preparing regulatory documents for public disclosure.
Familiarity with:
Clinical Trial Registry System (CTRS)
NIH Protocol Registration System (PRS)
ClinicalTrials.gov, EudraCT, EU CTIS, and other registries
Experience in redaction/anonymization of clinical trial documents.
Equal Opportunity Statement
Amgen is an Equal Opportunity Employer. We provide equal consideration to all applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We are committed to providing reasonable accommodations to individuals with disabilities during the application and interview process, while performing essential job functions, and in accessing other employment benefits. To request an accommodation, please contact us.
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