Job Description
Your Role
Support regulatory submission processes and maintenance of Marketing Authorizations for the assigned LAS cluster countries: Chile, Argentina, Paraguay, Uruguay, and Bolivia. Ensure the labeling of assigned products complies with regulatory requirements. Actively participate in change control processes. Guarantee the timely update of regulatory databases.
What you’ll be doing
- Support the submission of regulatory dossiers assigned for new product launches or for the maintenance of marketing authorizations (renewals, variations).
- Provide regulatory support to different areas of the company.
- Participate in the evaluation of change controls, risk assessments, and related activities.
- Ensure regulatory compliance during the review and approval of assigned printed materials.
- Support assigned labeling update processes.
- Ensure the timely update of regulatory databases such as RIM and CCDS. <...