Global Regulatory Writing - Senior Associate

Amgen Technology; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Amgen Hyderabad is seeking an experienced regulatory document professional to author routine to moderately complex regulatory documents, including ICFs, PLPS, CSRs, and amendments. You will manage versions, track deliverables, and ensure QC-ready, inspection-ready outputs.

Collaborate with Clinical, Safety, Regulatory and Study teams to resolve comments, participate in meetings, and elevate risks and timelines. Requires a Masters degree and 5–8 years of directly related experience.

Qualifications

• Masters degree and 5 to 8 years of directly related experience.

Responsibilities

• Independently author routine to moderately complex regulatory documents (ICFs, PLPSs, CSRs, amendments).
• Manage document versions, reviewer comments, and approval workflows end-to-end.
• Ensure documents are scientifically accurate and aligned with data and program goals.
• Prepare QC-ready and inspection-ready documents per SOPs and regulatory requirements.
• Support audits/inspections with document history and rationale.
• Collaborate with Clinical, Safety, Regulatory and Study teams to address inputs and feedback.
• Participate in document-related meetings and escalate risks/timeline challenges.
• Track deliverables and maintain adherence to timelines.
• Participate in trainings and continuous process improvements.
• Demonstrate consistent, on-time delivery of assigned deliverables.

Skills

Cross-functional stakeholder mgmt

Communication & presentation

Negotiation & conflict resolution

Strategic thinking & decision-making

Ownership & accountability

Timeline planning & execution

Risk identification & mitigation

Comment resolution

Document management systems

Education

Masters degree

Job description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the worlds toughest diseases, and make peoples 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 whats 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 elevate 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:

• Masters 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.