Company: Indegene
Position: Senior Regulatory Associate
Qualification: B.Pharm, M.Pharm, Pharm.D, MSc
Experience: 4-6 years in EU/ASEAN markets
Location: Bangalore, Hyderabad (Office-based/Hybrid)
Industry Type: Pharma / Healthcare / Clinical Research
Functional Area: Regulatory Affairs
Application Deadline: 25th August 2025
About Indegene
Indegene is a leading healthcare solutions provider that partners with biopharmaceutical, emerging biotech, and medical device companies to accelerate product development, regulatory approvals, and commercialization. With a blend of healthcare expertise, advanced technology, and agile methodologies, Indegene enables organizations to deliver patient-centric, scalable, and omnichannel healthcare solutions.
The company specializes in regulatory submissions, medical affairs, clinical research, and digital healthcare innovations, making it a preferred employer for professionals in the pharma and life sciences sector.
Job Description: Senior Regulatory Associate
Key Responsibilities:
✔ Prepare and manage regulatory dossiers for EU & ASEAN markets
✔ Coordinate with health authorities for submissions, approvals, and post-approval compliance
✔ Hands-on experience in Module 1 document preparation (submission forms, cover letters, comparison tables)
✔ Ensure compliance with EU & ASEAN regulatory guidelines for drugs, devices, and biologics
✔ Review and QC regulatory documents prepared by junior team members
✔ Work closely with R&D, QA, and manufacturing teams for dossier compilation
✔ Track submissions using regulatory trackers and ensure timely approvals
✔ Provide regulatory intelligence on CTA, drug registration, and compliance requirements
✔ Mentor new hires on SOPs, regulatory processes, and best practices
Skills & Qualifications:
✅ Education: B.Pharm / M.Pharm / Pharm.D / MSc
✅ Experience: 4-6 years in EU/ASEAN regulatory affairs
✅ Strong knowledge of eCTD, Veeva Vault, Trackwise, RIMS (Preferred)
✅ Proficiency in MS Office, Adobe Acrobat, regulatory publishing tools
✅ Excellent communication, leadership, and project management skills
