Regulatory Affairs Labeling

Parexel International India safety services·Remote

Pay not statedJunior levelFull-timeRemote

Apply on Parexel International India safety services' site Track your applications and see your fit: start free

Read from the company's own careers page; you apply on their site.

How well do you fit this job?

Upload your resume to see each requirement checked against your profile, in under a minute.

Check my fit

Hard to read?

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