Regulatory Affairs Labeling
RemoteFull-timeJunior levelPosted 1 week ago
Pharma role at Parexel International India safety services. Remote.
About the role
Perform regulatory impact assessments for change controls raised in TrackWise for medicinal products registered via the Centralized Procedure (CP) Manage product information updates, including creation and updates of the Company Core Data Sheet (CCDS), applying clinical expertise Prepare and submit variations, notifications, and renewals to Health Authorities
What you'll do
- Perform regulatory impact assessments for change controls raised in TrackWise for medicinal products registered via the Centralized Procedure (CP)
- Manage product information updates, including creation and updates of the Company Core Data Sheet (CCDS), applying clinical expertise
- Prepare and submit variations, notifications, and renewals to Health Authorities
- Respond to Health Authority questions on submissions
- Coordinate labeling updates, including translations, with team members and client stakeholders
What you need
- Regulatory affairs