Global Regulatory Writing – Senior Associate

Amgen SA; Hyderabad; On-site; INR 800,000 - 1,500,000; Full time

Job summary

Amgen is seeking a Regulatory Documentation Specialist to independently author regulatory documents such as ICFs, amendments, CSR sections, and related updates. You will manage end-to-end review workflows, ensuring accuracy and alignment with program objectives while supporting audits and inspections.

The role requires a Master’s degree with 5–8 years of directly related experience, strong collaboration across Clinical, Safety, Regulatory, and Study teams, and a focus on timely, compliant

Qualifications

• Master’s degree and 5–8 years of directly related regulatory experience.
• Experience authoring regulatory documents (ICFs, amendments, CSR sections, PS/PLPS), aligned with program objectives.
• Familiarity with SOPs, regulatory guidance, and inspection readiness.

Responsibilities

• Author routine to moderately complex regulatory documents.
• Manage document versions, reviewer comments, and approvals end-to-end.
• Ensure documents are scientifically accurate and aligned with source data.

Skills

Cross-functional collaboration

Communication skills

Negotiation

Strategic thinking

Ownership

Education

Master’s degree

Tools

SharePoint

RIM tools

Document management systems

Job description

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 raise 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.