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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, MPharm, PharmD, MDS, or BDS 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 | 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.