- Manage end-to-end CDSCO regulatory projects for Medical Devices and Cosmetics.
- Handle CDSCO registrations, import licenses, manufacturing licenses, permissions, and other regulatory approvals.
- Review technical documentation and ensure compliance with applicable CDSCO regulations.
- Prepare, verify, and submit applications through the CDSCO SUGAM Portal.
- Coordinate with clients to collect, review, and validate regulatory documents.
- Follow up with clients regarding pending documents and approvals.
- Monitor project timelines and ensure timely completion of all assigned projects.
- Liaise with CDSCO officials, testing laboratories, manufacturers, and other stakeholders whenever required.
- Stay updated with changes in CDSCO guidelines, Medical Devices Rules, Cosmetics Rules, and other applicable regulations.
- Work closely with the Business Development team to provide technical support during client discussions whenever required.
Preferred candidate profile
- Strong knowledge of CDSCO regulations and regulatory procedures.
- Hands-on experience with the CDSCO SUGAM Portal.
- Excellent knowledge of Medical Devices Rules, 2017.
- Valuable understanding of the Drugs & Cosmetics Act, 1940 and related Rules.
- Strong documentation review and regulatory compliance skills.
- Project management and team leadership abilities.
- Excellent communication and client coordination skills.
- Ability to manage multiple regulatory projects simultaneously.
- Proficiency in Microsoft Office (Excel, Word, Outlook).