Amgen is inviting applications for the position of Global Regulatory Writing – Senior Associate in Hyderabad, India. The role falls under the Regulatory career category and involves authoring regulatory documents, managing document review and approval workflows, coordinating with cross-functional teams, and ensuring compliance with applicable regulatory requirements.
Candidates with a master’s degree and 5–8 years of directly related experience can review the eligibility criteria and apply through the official Amgen careers portal.
Job Details
| Particulars | Details |
|---|---|
| Company | Amgen |
| Job Title | Global Regulatory Writing – Senior Associate |
| Job Requisition ID | R-257583 |
| Department | Regulatory |
| Job Location | Hyderabad, India |
| Work Mode | On-site |
| Employment Type | Full-time |
| Required Experience | 5–8 years of directly related experience |
| Minimum Qualification | Master’s degree |
| Application Link | Official Amgen Careers Portal |
Position
Global Regulatory Writing – Senior Associate
The selected candidate will independently prepare routine to moderately complex regulatory documents, manage document lifecycle activities, coordinate reviews, and ensure scientific accuracy, consistency, and compliance with regulatory requirements.
Responsibilities
- Author regulatory documents, including Informed Consent Forms (ICFs), ICF amendments, PLPSs and amendments, Clinical Study Report (CSR) sections, Patient Lay Summaries (PLS), protocol amendments, country-specific protocol supplements, and minor or focused Investigator’s Brochure (IB) updates.
- Manage document versions, reviewer comments, and approval workflows from initiation to completion.
- Ensure documents are scientifically accurate, internally consistent, and aligned with source data and program objectives.
- Prepare quality-control-ready and inspection-ready documents in accordance with applicable guidance, SOPs, and regulatory requirements.
- Support audits and inspections by providing document histories, supporting documentation, and justifications when required.
- Collaborate with Clinical, Safety, Regulatory, and Study teams to clarify inputs, resolve comments, and incorporate feedback.
- Participate in document-related meetings as required.
- Escalate risks, scope changes, and timeline challenges to managers.
- Track assigned deliverables and meet agreed timelines.
- Participate in internal training, knowledge-transfer sessions, and continuous process improvement initiatives.
Eligibility and Qualifications
Candidates applying for the Amgen Global Regulatory Writing – Senior Associate position must have:
- A master’s degree.
- 5–8 years of directly related professional experience.
Required Skills
The job description highlights the following collaboration, project management, and operational skills:
Collaboration and communication
- Cross-functional stakeholder management
- Effective communication and presentation
- Negotiation and conflict resolution
- Strategic thinking and decision-making
- Ownership and accountability
Project management and operations
- Timeline planning and execution
- Managing multiple deliverables simultaneously
- Risk identification and mitigation
- Review coordination and comment resolution
- Proficiency in document management systems, Regulatory Information Management (RIM) tools, SharePoint, and document authoring platforms
Regulatory writing
- Regulatory document authoring
- Document version control and approval workflows
- Scientific accuracy and consistency
- Quality control and inspection readiness
- Regulatory compliance and audit support
Application Details
