Associate Manager – Regulatory Solutions (Medical Writing) – Bangalore
Job Summary
Indegene is seeking an experienced Associate Manager - Regulatory Solutions to lead and manage complex medical writing projects for global clinical and regulatory submissions. This hybrid role in Bangalore is ideal for senior regulatory professionals with strong knowledge of CTD Modules 2 and 5, document leadership, team mentoring, and structured content management. If you're passionate about healthcare innovation and want to work at the intersection of technology and regulatory science, this is your opportunity.
Key Responsibilities
Independently author and review clinical and regulatory documents: CSRs, protocols, amendments, IBs, ICFs, and CTD Modules 2.4 to 2.7 and 5.2
Lead cross-functional teams to develop strategic medical writing deliverables
Develop and oversee project timelines, work plans, and documentation workflows
Apply lean authoring and structured content management practices
Mentor junior writers and manage team performance and delivery
Conduct regulatory literature searches and maintain document compliance
Drive consistency in messaging and document quality across submissions
Coordinate and lead kickoff meetings, quality control, and finalization processes
Support training initiatives and participate in department-level improvement programs
Required Skills & Qualifications
Education: MBBS/PhD/MDS/BDS/MPharm/PharmD
Experience: 10–12 years in regulatory medical writing with global submissions
Proficient in CTD Modules 2 & 5, CSRs, IBs, protocols, amendments, ICFs
Understanding of regulatory and regional guidelines (US, EU)
Strong scientific interpretation and regulatory argument development
Excellent skills in MS Word, document management systems, and writing tools
Demonstrated people management experience (2+ years)
Ability to lead large document teams across multiple therapeutic areas
Strong organizational, time management, and communication skills
Perks & Benefits
Hybrid work model offering work-life balance
Global exposure in healthcare and life sciences
Career growth and mentorship from industry leaders
Competitive compensation and performance incentives
Inclusive and diverse work culture
Company Description
Indegene is a global leader in healthcare solutions, combining cutting-edge technology with deep domain expertise. We partner with life sciences companies to accelerate medical innovations, regulatory documentation, and digital transformation worldwide.
Work Mode
Hybrid – Bangalore, India
Call to Action
Ready to lead impactful regulatory writing initiatives at a global scale?
Apply now and take your career to the next level with Indegene.
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