Job Title: Lead – Regulatory Writing
Location: Bangalore, Karnataka, India
Company: Indegene
Work Mode: On-site
Job Summary:
Indegene is hiring a Lead – Regulatory Writing professional in Bangalore to support global health authority submissions. The role involves preparing eCTD and non-eCTD dossiers, managing regulatory publishing processes, and ensuring quality submissions for markets including the US, EU, Canada, and GCC. This is a great opportunity for professionals experienced in regulatory writing and submission publishing to work at the intersection of healthcare and technology.
Key Responsibilities:
Prepare and compile global regulatory dossiers in eCTD and non-eCTD formats per HA and client-specific guidelines.
Maintain excellent working knowledge of regional regulations and submission structures.
Perform regulatory publishing tasks, QC checks, and issue resolution.
Ensure high-quality submission deliverables and adherence to timelines.
Publish clinical documents while maintaining internal/external standards and KPIs.
Handle submission dispatch via portals or directly to health authorities.
Ensure minimized QC findings and no rework on finalized submissions.
Support initial and post-approval submission processes.
Required Skills & Qualifications:
5+ years of experience in regulatory publishing and submission management.
Hands-on expertise in global regulatory submission formats and tools.
Strong familiarity with CSR publishing, Word/PDF formatting, and document QC.
Thorough knowledge of HA requirements for US, EU, Canada, and GCC regions.
Proficiency in publishing software tools and document quality control processes.
Ability to interpret and apply Agency regulations and guidelines.
Perks & Benefits:
Opportunity to work in a fast-growing, technology-led healthcare company.
Exposure to global regulatory frameworks and processes.
Career development support and cross-functional learning opportunities.
Inclusive and diverse work culture.
Company Description:
Indegene is a leading global healthcare solutions provider that blends deep scientific expertise with digital and technology capabilities. With a presence across key global markets, Indegene empowers life sciences organizations to be future-ready and patient-centric.
Work Mode:
On-site (Bangalore)
Call to Action:
Ready to take your regulatory career to the next level? Apply now to become a Lead – Regulatory Writing expert at Indegene. Join a purpose-driven organization shaping the future of healthcare technology.
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