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Associate Manager- Regulatory Solutions

10-12 years
Not Disclosed
10 July 31, 2025
Job Description
Job Type: Full Time Education: MBBS/PhD/MDS/BDS/MPharm/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.