Associate Manager – Regulatory Solutions | Indegene, Bangalore
Job Summary:
Indegene is seeking an experienced Associate Manager – Regulatory Solutions to lead complex medical writing and clinical documentation projects in Bangalore, India. This full-time on-site role is ideal for professionals with 10 to 12 years of experience in authoring and reviewing regulatory and clinical documents such as CTD Module 2 & 5, CSRs, protocols, and IBs. The role requires strategic leadership, cross-functional collaboration, and mentoring junior writers in regulatory content development.
Key Responsibilities:
Lead development and review of CTD Modules 2 & 5, CSRs, protocols, IBs, ICFs, and amendments
Coordinate document preparation and review across global cross-functional teams
Apply lean authoring and structured content management
Create project and work plans, manage timelines, and deliverables
Guide and mentor junior writers, ensuring consistency and adherence to regulatory standards
Conduct literature reviews and interpret scientific data to build robust regulatory narratives
Oversee document finalization, quality control, and sign-off
Ensure communication and collaboration across stakeholders
Stay current with global regulatory guidelines and industry best practices
Contribute to departmental initiatives and regulatory intelligence
Required Skills & Qualifications:
Education: MBBS, PhD, MPharm, PharmD, MDS, or BDS
10–12 years of experience in clinical and regulatory medical writing
Deep understanding of CTD structure and global regulatory filing requirements
Hands-on experience with documents like Module 2.4–2.7, 5.2, CSRs, protocols, IBs
Knowledge of regulatory requirements (ICH, US FDA, EMA)
Strong scientific background with ability to interpret clinical data
Expertise in Microsoft Word, document management systems, and template tools
Strong people management and leadership skills (2+ years)
Excellent communication, organizational, and time management abilities
Adaptable across therapeutic areas and regulatory document types
Perks & Benefits:
Global career advancement opportunities
Competitive compensation (not disclosed)
Work at the intersection of healthcare and technology
Leadership mentoring and continuous learning
Inclusive and diverse workplace culture
Stability of a profitable, high-growth healthcare company
About the Company:
Indegene is a global technology-led healthcare solutions provider. Known for its innovation at the intersection of pharmaceuticals, life sciences, and digital transformation, Indegene empowers healthcare organizations to be future-ready by blending science, data, and cutting-edge technology.
Work Mode: On-site (Bangalore, Karnataka, India)
Call-to-Action:
Ready to take charge of high-impact regulatory writing projects?
Apply now to join Indegene’s expert team and shape the future of global clinical and regulatory documentation.
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