Global Regulatory Writing – Senior Associate

Global Regulatory Writing – Senior Associate

India - Hyderabad

Apply Now

JOB ID: R-257583

LOCATION

India - Hyderabad

WORK LOCATION TYPE: On Site

DATE POSTED: Oct. 12, 2026

CATEGORY: Regulatory

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

Key Responsibilities

• Independently author routine to moderately complex regulatory documents, including: ICFs and ICF Amendments, PLPSs and PLPS Amendments, CSR sections (synoptic, abbreviated, and standard reports; pivotal CSRs with guidance/support), PLS, Protocol Amendments and Country-Specific Protocol Supplements, IB updates (minor/focused updates).

• Manage document versions, reviewer comments, and approval workflows end-to-end for assigned documents.

• Ensure assigned documents are scientifically accurate, internally consistent, and aligned with source data and program objectives.

• Prepare documents that are QC-ready and inspection-ready, adhering to applicable guidance documents, SOPs, and regulatory requirements.

• Support audits and inspections by providing document history, supporting documentation, and justification/rationale as required.

• Collaborate with Clinical, Safety, Regulatory, and Study teams to clarify inputs, resolve comments, and efficiently incorporate feedback.

• Participate in document-related meetings, as required.

• Proactively escalate risks, scope changes, and timeline challenges to managers.

• Track assigned deliverables and ensure adherence to agreed timelines.

• Participate in internal training programs, knowledge-transfer sessions, and continuous process improvement initiatives.

• Demonstrate consistent, on-time delivery of assigned deliverables.

• Collaboration Skills

• Cross-functional stakeholder management

• Effective communication and presentation skills

• Negotiation and conflict resolution

• Strategic thinking and decision-making

• Ownership and accountability

• Project Management and Operational Skills

• Timeline planning and execution

• Managing multiple deliverables simultaneously

• Risk identification and mitigation

• Review coordination and comment resolution

• Proficiency in document management systems, RIM tools, SharePoint, and document authoring platforms

Basic Qualifications:

• Master’s degree and 5 to 8 years of directly related experience

• EQUAL OPPORTUNITY STATEMENT

• Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

• We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

• Apply Now

• SHARE THIS JOB

• Facebook

• X

• LinkedIn

• Email

• Privacy Statement

• Live. Win. Thrive.

• Sign Up for Job Alerts

• Stay up to date on Amgen news and opportunities. Sign up to receive alerts about positions that suit your skills and career interests.

• Email*

• Interested In

• CategorySelect oneAdministrativeBusiness DevelopmentClinicalClinical DevelopmentCollege JobComplianceCorporate ServicesEngineeringFinanceGovernment AffairsHealth EconomicsHuman ResourcesInformation SystemsLaw/LegalLogisticsMaintenanceManufacturingMarketingMedical AffairsMedical ServicesOperationsProcess DevelopmentProcurementProject ManagementPublic RelationsQualityRegulatoryResearchSafetySalesSales & Marketing OperationsScientificStrategy and InnovationSupply ChainTrainingValue and AccessWhen autocomplete results are available use up and down arrows to review and enter to select. Touch device users, explore by touch or with swipe gestures.

• LocationWhen autocomplete results are available use up and down arrows to review and enter to select. Touch device users, explore by touch or with swipe gestures.

• Add

• Regulatory, Hyderabad, Telangana, IndiaRemove

• Confirm Email

• By submitting your information, you acknowledge that you have read our privacy policy (this content opens in new window) and consent to receive email communication from Amgen.

• Sign Up