Job Title:
Associate – Regulatory Writing
Job Information:
Job ID: R-224183
Location: India – Hyderabad
Work Type: On-site
Date Posted: August 29, 2025
Category: Regulatory
Company: Amgen
About Amgen:
Amgen is a global leader in biotechnology, leveraging the best of biology and technology to develop therapies that address the world’s most serious illnesses. With over 40 years of innovation, Amgen remains at the forefront of science, using human genetic data and cutting-edge tools to discover and deliver life-changing medicines for millions of patients worldwide.
Role Summary:
As an Associate in Regulatory Writing, you will be responsible for preparing clinical regulatory documents for public disclosure, ensuring compliance with global regulatory requirements and internal policies. The role also includes document anonymization, redaction of commercially confidential information, and coordination of clinical trial transparency and disclosure activities.
Key Responsibilities:
Document Preparation & Disclosure:
Prepare clinical regulatory documents for public disclosure.
Anonymize personal data and redact commercially confidential information (CCI) per regulations and internal strategy.
Ensure consistency, quality, and submission readiness of all documents.
Maintain written redaction strategies for studies and products.
Project Coordination & Execution:
Manage timelines and coordinate work across global teams.
Execute clinical trial transparency and disclosure processes in line with regulations, SOPs, and Amgen policies.
Record documentation for assigned responsibilities and action items.
System & Process Support:
Serve as Process Administrator for the Clinical Trial Registry System (CTRS):
Support users, manage system access, troubleshoot issues.
Generate and manage reports, trackers, portals, and metrics.
Assist in audit and inspection readiness for trial disclosure activities.
Collaboration & Communication:
Collaborate with cross-functional teams to resolve challenges and escalate issues.
Support stakeholder inquiries and ensure clear communication across functions.
Required Skills & Competencies:
Ability to interpret data and apply it to real-world regulatory requirements.
Strong attention to detail, follow-through, and multi-tasking abilities.
Ability to work under controlled processes with a high level of accuracy.
Excellent written and spoken English communication skills.
Strong problem-solving and project management skills.
Basic Qualifications:
Bachelor’s degree
Minimum of 1 year of experience working with regulatory documents in the biotech or pharmaceutical industry
Familiarity with:
Clinical research processes
Clinical regulatory documentation
Trial disclosure regulations, guidelines, and best practices
Preferred Qualifications:
Over 1 year of experience in preparing regulatory documents for public disclosure
Familiarity with:
Clinical Trial Registry Systems (CTRS)
NIH Protocol Registration System (PRS)
ClinicalTrials.gov, EudraCT, EU CTIS, and other public registries
Redaction/anonymization of clinical trial documents
Equal Opportunity Statement:
Amgen is an Equal Opportunity Employer. We value diversity and do not discriminate based on race, color, religion, gender, sexual orientation, gender identity, national origin, veteran status, or disability.
We are committed to providing reasonable accommodations to individuals with disabilities throughout the application, interview, and employment process. If you need an accommodation, please contact us.
Apply Now:
Click Here to Apply
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