Job Description
The Position
The Regulatory Affairs Intern provides support in medium and low complexity processes, using the company's tools, software and systems. The above is in compliance with the provisions of official procedures. Hybrid model - 2x / week
Responsabilities
✓Support in the preparation, submission and monitoring of the necessary documentation for the different regulatory procedures such as: Registration, Re-registration, Technical updates, Modifications to the health registry, corrections as applicable.
✓Daily review the status/approvals of the procedures in the external computer programs of the regulatory agencies and check that the different databases and check lists are up to date.
✓Provide support to keep the Good Manufacturing Practices certificates of all the corresponding plants for the products in charge up to date.
✓Keep the electronic and physical file updated in accordance with the established procedure.
✓Provide support in the entry of deficiency letters received from the health authority.
✓Establish good working relationships with both internal and external personnel (regulatory agency) maintaining a professional image on behalf of the company.
✓Support artworks production and review through the company's internal system.
✓Protect company information, ensuring that it is not disclosed except when necessary (Legal representative, health agency) and when it is duly covered with the appropriate confidentiality agreements.
✓Carry out the required training within the established times.
✓Request for translation support for regulatory processes.
✓Update the technical sheets and inserts on the designated internal platforms.
Required Education, Experience and Skills
Required Education:
Pharmaceutical Chemist
Experience:
Minimum 6 months of experience in areas of regulatory affairs.
Basic knowledge of current regulations for pharmaceutical products and medical devices
Knowledge in document management
Interest in areas of administrative support
📌 Regulatory Affairs Intern (Lima)
🏢 Organon
📍 Lima