Career Category
Regulatory
Job Description
Group Purpose
To prepare scientific and regulatory submission documents that comply with global regulatory standards.

Job Summary
To author and gain approval of scientific and regulatory submission documents that comply with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. This role serves as functional area lead on product teams, leads writing activities for complex product submissions providing functional area expertise, trains and mentors more junior writers, and leads departmental activities.

Key Activities
Independently:
- Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents;




- Conduct the formal review and approval of authored documents, following applicable standard operating procedures;
- With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications;
- Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
- Provide functional area input for Global Regulatory Plan and team goals
- oversee the work of contract and freelance writers train, mentor, or supervise more junior medical writers, as assigned
- lead departmental and cross-departmental initiatives, as appropriate
- Generate document timeline and keep abreast of relevant qualified information and technology

Knowledge and Skills
Required Knowledge and Skills:
- Ability to independently analyze scientific data and interpret its significance in practical applicatio

📌 Global Regulatory Writing – Senior Manager (Hyderabad)
🏢 AMGEN
📍 Hyderabad