Seniorr Associate Regulatory Writing

Amgen · Hyderabad

  • Experience5–7 yrs
  • SalaryNot disclosed
  • Work modeonsite
  • Levelsenior
  • Posted16 Sept 2026
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About Amgen

Amgen is hiring in Hyderabad in pharma biotech. This role looks for around 5+ years of experience.

Skills

  • regulatory writing
  • document management systems
  • RIM tools
  • SharePoint
  • authoring platforms
  • clinical research
  • regulatory affairs
  • quality control
  • project management
  • timeline planning
  • risk management

The role

A regulatory writer at a biotechnology company authors clinical and regulatory documents using regulatory writing, document management systems, and RIM tools, coordinating review workflows and inspection-ready submissions with clinical, safety, and regulatory stakeholders. The role also applies SharePoint and project management to manage timelines and deliverables.

Full 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.

Roles & Responsibilities

Independently author routine to moderately complex documents, including:ICFs and ICF amendmentsPLPS and AmendmentsSections of CSRs (synoptic, abbreviated and standard; pivotal CSRs with support)Protocol Amendments and Country Specific Protocol SupplementIB updates (minor / focused updates)Manage document versions, reviewer comments, and approval flows end to end for assigned documents.Ensure assigned documents are scientifically accurate, consistent across sections and aligned with source data and program intentPrepare documents to be QC and inspection ready, adhering to Guidance documents/SOPsSupport audits or inspections by providing documentation history and rationale when needed.Engage with Clinical, Safety, Regulatory and Study teams to clarify inputs, resolve comments and incorporate feedback efficientlyParticipate in document related meetings as required.Escalate risks, scope changes, or timeline pressures early to Managers.Track assigned deliverables and timelines.Participate in internal trainings, KT sessions, and process improvements.Consistent on time delivery

Collaboration Skills:

Cross-functional stakeholder managementCommunication and presentation skillsNegotiation and conflict resolutionStrategic thinking and decision makingOwnership and accountability Project Management & Operational SkillsTimeline planning and executionManaging multiple deliverables simultaneouslyRisk identification and mitigationReview coordination and comment resolutionWorking effectively with document management systems, RIM tools, SharePoint, and authoring platforms

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.