Indegene Hiring Regulatory Writer Job in India (Lead/Associate Manager) for hybrid roles across India. Apply online for regulatory writing jobs today.
Company: Indegene Pvt. Ltd.
Post Name: Lead / Associate Manager – Regulatory Writer
Location: Bangalore, Hyderabad, Mumbai, Pune, Delhi (Hybrid)
Qualification: B.Pharm / M.Pharm / Pharm.D / M.Sc / B.Sc / Life Sciences
Experience: 5 – 8 Years
Job Type: Full-Time, Hybrid
Job Status: Verified Job
Application Mode: Online Application
About Indegene
Indegene Pvt. Ltd. is a global healthcare solutions provider that partners with life sciences organizations to accelerate drug development, improve regulatory compliance, and enhance patient outcomes. With over two decades of experience, Indegene combines medical expertise, digital innovation, and regulatory excellence to deliver world-class solutions for the pharmaceutical and healthcare industries. Indegene Hiring Regulatory Writer Job in India
As part of its growing Clinical Research and Regulatory Affairs division, Indegene is now hiring experienced Regulatory Writers to join its expanding global documentation team.
This is an excellent opportunity for professionals passionate about regulatory writing, clinical research, and global documentation standards. Indegene Hiring Regulatory Writer Job in India
Position: Lead / Associate Manager – Regulatory Writer
Work Mode: Hybrid (available across major cities: Bangalore, Hyderabad, Mumbai, Pune, and Delhi)
This role involves leading the authoring, review, and submission of regulatory documents such as Clinical Study Reports (CSRs), Investigator Brochures (IBs), Clinical Protocols, Informed Consent Forms (ICFs), and Clinical Narratives in compliance with global standards. Indegene Hiring Regulatory Writer Job in India
Key Responsibilities
- Lead preparation and submission of regulatory documents including CSRs, IBs, Clinical Protocols, ICFs, and Clinical Narratives.
- Ensure documents meet global regulatory standards, sponsor requirements, and internal quality expectations.
- Collaborate with cross-functional teams (clinical operations, medical writing, safety, quality assurance) to collect and validate data inputs.
- Maintain document quality, consistency, and traceability throughout the regulatory life cycle.
- Mentor and train junior writers; contribute to process improvement initiatives and editorial oversight.
Required Qualifications
- Experience: 5–8 years in regulatory writing within the clinical research domain.
- Proficiency in: authoring CSRs, IBs, Clinical Protocols, ICFs, and Clinical Narratives.
- Strong knowledge of ICH-GCP guidelines, regulatory submission processes, and industry documentation standards.
- Excellent writing, editing, and project management skills.
- Ability to manage multiple documents and deadlines independently.
- Preferred: prior experience as Lead Writer or Associate Manager in regulatory writing.
- Indegene Hiring Regulatory Writer Job in India
Skills & Competencies
- Deep understanding of regulatory documentation and submission requirements.
- Excellent communication and collaboration with cross-functional teams.
- Strong attention to detail, analytical mindset, and scientific writing capability.
- Familiarity with clinical data structures, templates, and document management tools.
- Indegene Hiring Regulatory Writer Job in India
Benefits
- Hybrid work flexibility with the option to work from major Indian cities.
- Opportunity to lead and manage regulatory writing projects across therapeutic areas.
- Exposure to global regulatory frameworks and cross-functional collaboration.
- Competitive compensation and performance-based growth opportunities.
- Access to continuous professional learning and leadership development programs.
Work Locations
Hybrid opportunities available in:
📍 Bangalore
📍 Hyderabad
📍 Mumbai
📍 Pune
📍 Delhi
How to Apply
Interested and eligible candidates can send their updated resume and a brief cover letter to:
📧 Shloka@indegene.com
Alternatively, you may apply through the Indegene Careers Portal or refer to the official job application link shared by the recruiter.
About the Company
Indegene is a global healthcare transformation company that works with life sciences clients to enable clinical, medical, and commercial success through digital and regulatory innovation. Its team of professionals across 20+ countries collaborates to drive smarter compliance, faster drug development, and better patient engagement. Indegene Hiring Regulatory Writer Job in India
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
