Job Title:
Associate – Regulatory Writing
Job Information:
Job ID: R-224184
Location: India – Hyderabad
Work Type: On-site
Date Posted: August 29, 2025
Category: Regulatory
Company: Amgen
About Amgen:
Amgen is a pioneer in biotechnology, harnessing the best of biology and technology to develop therapies for the world’s toughest diseases. For over 40 years, Amgen has remained on the cutting-edge of innovation, using human genetic data and scientific research to discover, develop, manufacture, and deliver life-saving medicines to millions of patients worldwide.
Position Summary:
The Associate – Regulatory Writing will play a key role in clinical trial disclosure by preparing regulatory documents for public release, ensuring compliance with global data transparency regulations, and supporting system/process administration. This role will collaborate with cross-functional teams and contribute to audit readiness, documentation management, and process improvement.
Key Responsibilities:
Document Preparation & Review:
Prepare clinical regulatory documents for public disclosure.
Anonymize personal data and redact commercially confidential information (CCI) in line with global regulatory requirements.
Ensure documents are consistent in quality, submission-ready, and delivered on time.
Maintain written redaction strategies for each study/product.
Project Coordination & Team Collaboration:
Coordinate work and manage timelines across project teams.
Act as the tactical point of contact for assigned areas, tracking responsibilities and action items.
Collaborate with internal teams to resolve issues and escalate when necessary.
Support clinical trial disclosure audits and inspections.
Systems & Process Management:
Administer the Clinical Trial Registry System (CTRS):
Support users, manage system access, resolve technical issues.
Execute clinical trial disclosure processes in alignment with Amgen SOPs, policies, and regulatory timelines.
Generate and manage reports, trackers, portals, and metrics related to disclosure activities.
Required Skills & Competencies:
Strong ability to interpret and apply data/information in regulatory contexts.
Highly self-motivated with attention to detail and strong follow-through.
Proficient in controlled documentation processes.
Excellent written and verbal English communication skills.
Effective project management skills, with the ability to prioritize and meet deadlines.
Solid problem-solving capabilities and critical thinking.
Basic Qualifications:
Bachelor’s degree
Minimum 1 year of experience with regulatory documents in a biotech or pharmaceutical environment
Familiarity with:
Clinical research processes
Regulatory documents such as protocols, CSRs, and trial summaries
Disclosure regulations, guidelines, and best practices
Preferred Qualifications:
Over 1 year of experience preparing regulatory documents for public disclosure
Experience with:
Clinical Trial Registry Systems (CTRS)
NIH 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, committed to a diverse and inclusive workplace. All qualified applicants will receive consideration without regard to:
Race, color, religion
Gender, gender identity, or sexual orientation
National origin, veteran status, or disability
Amgen also provides reasonable accommodations for individuals with disabilities to participate in the application or interview process and to perform essential job functions.
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