Life Science Jobs | Roche is Hiring a Regulatory Information Specialist | Apply Now
Looking to build a global Roche career in high-impact Regulatory Affairs Jobs? Roche India is hiring a Regulatory Information Specialist, offering life science graduates a chance to work at the intersection of regulatory intelligence, FDA documentation, and drug development. This role is ideal for candidates seeking long-term growth in Life Science Jobs within a world-leading biopharmaceutical organization.
Job Details
- Position: Regulatory Information Specialist
- Job ID: 202602-102922
- Locations: Chennai / Hyderabad
About the Company
Roche is a global pioneer in pharmaceuticals and diagnostics, driven by innovation, science, and patient-centric solutions. Roche Services & Solutions (RSS) supports global operations by delivering end-to-end business and regulatory services. With a strong presence in India, Roche offers meaningful Life Science Jobs that contribute to improving healthcare outcomes worldwide.
Key Responsibilities
- Process and upload regulatory correspondence into RIM systems following eCTD structure
- Categorize metadata and track agency commitments and regulatory deadlines
- Extract critical data from FDA approval documents and Summary Basis of Approval
- Record clinical endpoints, statistical outcomes, and regulatory milestones
- Maintain data integrity by cross-verifying FDA sources
- Support internal audits and health authority inspections
Qualification
- Bachelor’s or Master’s Degree in Life Sciences, Clinical Research, or an equivalent field.
- 2–4 years of experience in Regulatory Operations, Document Management, or a related clinical research/ regulatory affairs role.
Skills Required
- Strong understanding of drug development and regulatory frameworks
- FDA literacy including CDER and CBER approval packages
- Hands-on experience with RIM tools such as Veeva Vault
- High attention to detail and accuracy in data management
- Ability to interpret clinical trial results and regulatory terminology
- Excellent written English and documentation skills
This opportunity at Roche is ideal for candidates aiming to establish a strong Roche career in Regulatory Affairs Jobs. With global exposure, regulatory intelligence work, and innovation-driven culture, this role offers a powerful launchpad for life science professionals seeking meaningful and future-ready Life Science Jobs.
