Regulatory Writing Associate Hiring at Amgen – Hyderabad

Regulatory Writing Associate Jobs at Amgen – Hyderabad

Apply for Regulatory Writing Associate role at Amgen in Hyderabad. Openings for BSc Science graduates with 1-2 years experience in regulatory documentation.

Associate, Regulatory Writing Opportunities for BSc Graduates at Amgen – Hyderabad Location

Amgen, a leading global biotechnology company, is hiring Associates in Regulatory Writing for its Hyderabad location. This is a full-time onsite opportunity ideal for candidates with a Bachelor’s degree in Science (BSc) and 1–2 years of experience in regulatory or clinical documentation within the pharmaceutical or biotech industry.

Key Responsibilities

• Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) to ensure submission readiness quality
• Ensures the consistency and accuracy of layouts, fonts, margins, styles, and spacing, logical content organization, and proper use of headings, tables, images, and footnotes applying Amgen submission readiness formatting guidelines to create professional documents
• Coordinates document collection with cross-functional team members and ensures publishing readiness of the documents
• Participates in collaborative team activities for noncomplex documents, including support to collect input from authors/reviewers
• Participates in the cross-functional document review process
• Participates in project management activities, i.e., timeline tracking and scheduling meetings with team members
• Learns and uses organizationally required authoring tools and technology platforms
• Attends cross-functional meetings with writers and departments, as appropriate, to share and gather information relevant for successful completion of assigned documents
• Documents in scope include, but are not limited to: Clinical Study Reports, Observational Research Study Reports, Plain Language Summaries, Investigator’s Brochures, local Risk Management Plans, noncomplex Original Protocols/ Protocol Amendments, Plain Language Protocol Summaries, and Informed Consent Forms
• Understands and complies with SOPs, templates, best practices, policies, Regulatory Writing Style Guides

Educational Qualification

Required:

• Bachelor’s Degree in Science (BSc) from an accredited university

Preferred:

• Background in medical, life sciences, or pharmaceutical sciences
• Exposure to statistical and medical communication principles

Experience Required

• 1–2 years of professional experience in regulatory or clinical documentation
• Familiarity with tools like Microsoft Office, SharePoint, and document management systems

Skill Set

• Strong verbal and written communication skills
• Ability to collaborate and coordinate across departments
• Attention to detail, with a focus on accuracy and compliance
• Time and project management skills with the ability to multitask

Location Details

Work Type: On-Site
City: Hyderabad, India

How to Apply

Interested candidates can apply directly on Amgen’s career portal.

Job Snapshot Table