Provide support in the maintenance and organization of regulatory files (electronic and paper) for proper tracking of information and archiving of regulated documents. Provide support in the preparation of technical documentation applicable to products and the submission/monitoring of authorisation requests, changes and renewals, as well as notification of medical devices and food supplements, in accordance with applicable regulatory requirements. It is obligatory to sign an agreement with a university.
No experienced required.
- Audit and update of regulatory correspondence files/logs, and submission archives
- Participate in dossier preparation and submission, assisting on products registration (human medicines, medical devices, cosmetics, food supplements, etc), variations, renewals, or any other activity regarding the maintenance of the dossiers (e.g., readability tests). These procedures could be National or European procedures (Centralized, Decentralized and Mutual Recognition Procedures).
- Keeping abreast of international legislation, guidelines, and customer practices in all countries that the company is working and acquire familiarity with regulations compliance for all companies’ products
- Collect and evaluate scientific data.
- Prepare labelling, PIL, SmPC and mock-ups of medicinal products, and adaptation to current QRDs.
- Advise clients and manufacturers on regulatory requirements.
- Using of specialist computer software and resources, as required (general office programs, Health Authorities portals and tools, etc).
- Liaising and negotiating with regulatory authorities.
Education and skills required:
- B.Sc. degree in life science (Chemistry, Biology, Pharmacy, etc).
- Master or related post-graduate course in RA.
- Awareness of processes for working in a regulated field.
- English level: High.