Amgen, a global biotechnology leader, is hiring for Associate Regulatory Writing and Sr Associate Regulatory Writing roles in Hyderabad, India. These positions offer the chance to work on clinical regulatory documents, disclosure processes, and contribute to advancing innovative medicines that impact millions worldwide.
If you’re passionate about clinical research, regulatory writing, and disclosure compliance, this is your opportunity to join a company that has shaped the biotech industry for over 40 years.
📌 Job Roles & Responsibilities
Associate Regulatory Writing (R-224167)
- Prepare clinical regulatory documents for public disclosure.
- Anonymize personal data and redact confidential information.
- Ensure submission readiness and timely handoffs.
- Record and maintain redaction strategies.
- Support trial disclosure audits and inspections.
- Manage CTRS system access, reports, trackers, and metrics.
Sr Associate Regulatory Writing (R-224172)
- Lead preparation of regulatory documents for public disclosure and public registries (e.g., ClinicalTrials.gov).
- Collaborate with cross-functional teams on redaction strategy and approvals.
- Ensure submission readiness and quality compliance.
- Support process improvements and trend analysis.
- Act as the primary point of contact for disclosure activities.
- Administer CTRS, generate reports, and maintain documentation.
🎓 Qualifications
Associate Role
- Bachelor’s degree.
- Minimum 1 year of experience with regulatory documents in biotech/pharma.
- Familiarity with clinical research, disclosure regulations, and best practices.
- Strong English communication and project management skills.
Sr Associate Role
- Bachelor’s degree.
- Minimum 2 years of experience preparing regulatory documents for public disclosure.
- Deep understanding of clinical regulatory documents and disclosure guidelines.
- Strong communication, negotiation, and stakeholder management skills.
💼 Why Join Amgen?
- Work with a global biotech leader driving medical innovation.
- Gain exposure to regulatory writing and clinical trial disclosure at scale.
- Career growth opportunities in a highly regulated and impactful field.
- Inclusive workplace culture with equal opportunity employment.
📍 Job Location
- Hyderabad, India (On-Site)
📝 How to Apply
Application Link for Associate Regulatory Writing
