1. Provide support with all (new applications, variations, renewals, advertising, etc.), submissions and document collection at COFEPRIS and other government agencies
2. Follow up on regulatory procedures filed with COFEPRIS
3. Maintain updated information on Lab. Grin products (Marketing Authorizations, Manufacturing sites, product information packages (PIPS), among others), shared through databases user for tender processes, advertising, pharmacovigilance, technovigilance, and other activities.
4. Request and verify that the designs of printed materials (boxes, labels, instructions, or inserts) correspond to the label designs authorized by COFEPRIS or other regulatory agencies for Grin products. 6. Maintain up-to-date information on Grin Laboratories products (registration, product characteristics, product information, etc.) shared in databases for bidding processes, advertising, pharmacovigilance and technovigilance activities, among others.
5. Manage appointment scheduling with COFEPRIS
6. Review the Official Gazette of the Federation (Diario Oficial de la Federación).
7. Manage the request and follow-up of GMP certificates for APIs and finished products (PT), ensuring accurate filing and continuous maintenance of an up-to-date database.

Administrative activities:

8. Manage and maintain updated databases, including SAP purchase, order tracking, and payment processing for materials and services related to RA department
9. Prepare DHL shipping labels and documentation for the shipment of samples and documents, both domestically and internationally.
10. Manage the execution and signature process of contracts and Confidentially Disclosure Agreements (CDAs) with suppliers, as well as developing and maintaining an up-to-date database of supplier contracts for RA department.
11. Monitor and control inventories of office supplies, consumables, and archived documentation
12. Provide administrative support of Regulatory Affairs department

Qualification and Experience

Education in Busiess administration, finance, legal matters or related feld is preferred.

5 years of experience in a similar administrative role, nice to have in the pharmaceutical industry.

English level: intermediate

Competencies