- Provide support with all (new applications, variations, renewals, advertising, etc.), submissions and document collection at COFEPRIS and other government agencies
- Follow up on regulatory procedures filed with COFEPRIS
- 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.
- 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.
- 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.
- Manage appointment scheduling with COFEPRIS
- Review the Official Gazette of the Federation (Diario Oficial de la Federación).
- 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
- Manage and maintain updated databases, including SAP purchase, order tracking, and payment processing for materials and services related to RA department
- Prepare DHL shipping labels and documentation for the shipment of samples and documents, both domestically and internationally.
- 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.
- Monitor and control inventories of office supplies, consumables, and archived documentation
- 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
Collaboration
Customer Centricity
Developing Talent
Innovation & Creativity
Process Excellence
Result Orientation
Stakeholder Management
Strategic Agility
- Provide support with all (new applications, variations, renewals, advertising, etc.), submissions and document collection at COFEPRIS and other government agencies
- Follow up on regulatory procedures filed with COFEPRIS
- 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.
- 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.
- 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.
- Manage appointment scheduling with COFEPRIS
- Review the Official Gazette of the Federation (Diario Oficial de la Federación).
- 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
- Manage and maintain updated databases, including SAP purchase, order tracking, and payment processing for materials and services related to RA department
- Prepare DHL shipping labels and documentation for the shipment of samples and documents, both domestically and internationally.
- 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.
- Monitor and control inventories of office supplies, consumables, and archived documentation
- 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
Collaboration
Customer Centricity
Developing Talent
Innovation & Creativity
Process Excellence
Result Orientation
Stakeholder Management
Strategic Agility
📌 **Regulatory Affairs Executive (Nayarit)
🏢 Lupin
📍 Nayarit