Sr Analyst, Regulatory Affairs

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

1. Support the submission of regulatory dossiers assigned for new product launches or for the maintenance of marketing authorizations (renewals, variations).
2. Provide regulatory support to different areas of the company.
3. Participate in the evaluation of change controls, risk assessments, and related activities.
4. Ensure regulatory compliance during the review and approval of assigned printed materials.
5. Support assigned labeling update processes.
6. Ensure the timely update of regulatory databases such as RIM and CCDS.
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