Laboratórios BASI – Industria Farmacêutica S.A., in Mortágua (Viseu-Coimbra), seeks to integrate a new employee into its Regulatory team:
REGULATORY AFFAIRS OFFICER (m/f)
Main responsabilities:
- Performing registration of the medicines and other health products in the applicable markets.
- Reviewing MA dossier for the Products, ensuring their compliance.
- Preparation of the dossier Modules and Dossier compilation for submission to the Regulatory Authority..
- Providing support to regulatory information requests from the Authority or customers, including MA Dossier compliance analysis and effective response to requests for information.
- Replying to deficiency letters that may arise after review by the Regulatory Authority.
- Contacting the Competent Authorities and Notified Bodies in order to update the status of the processes.
- Providing regulatory support in Licensing of Basi Laboratories products, namely:
• Preparing Dossiers for audits and deficiency letters requests arising from the received reports, under further review and approval by a qualified colleague.
• Monitoring audits feedback and subsequent response to requests arising from the received reports.
- Compiling and evaluating compliance of products and their documentation with all the requirements required by their own legislation for the submission/registration so that they can be placed on the market.
- Evaluating the conformity, according to internal and regulatory requirements, of the artworks, with regard to medical devices, food supplements, biocides, cosmetic and body care products and dangerous preparations.
- Making request for CPP’s, CVL’s, CNP’s, ect. to authorities
- Elaborating and updating security statements, PIF’s, PSDS, ect.
- Updating all the product regulatory information in the control tools in force.
Profile:
- Graduation or Master Degree in an area relevant to the function.
- Knowledge of Good Manufacturing Pratices, Guideline and Standards
- Experience in the Pharmaceutical Industry
- 2 years of experience in similar or relevant functions