PharSolution, a PharmaLex Company, is looking for a:
Regulatory Affairs Specialist
Your Job
- General Regulatory affairs support to clients.
- Preparation, submission and follow-up until approval with the Regulatory Authorities of Marketing Authorisations (MA) Applications, Mutual and Decentralised Procedures.
- Preparation, submission and follow-up until approval with the Regulatory Authorities of variations applications to MAs under the National, Mutual and Decentralised Procedures.
- Preparation, submission and follow-up until approval with the Regulatory Authorities of all Marketing Authorisations Applications Renewals and file consolidations.
- Preparation, submission and follow-up until approval with the Regulatory Authorities of all the wholesaler distribution authorizations.
- Preparation of all relevant translations of all regulatory procedures to be submitted to Authorities.
- Development of readability tests/bridging reports.
- Preparation and implementation of Product Labelling and PPP (printed Packaging Material).
- Translation (EN<>PT; PT<>EN) of scientific, technical and regulatory documentation.
- Client’s database update.
- Information to PV for xEVMPD database input feeding.
- Medical devices: Compliance assessment and notification of medical devices to INFARMED. Review of labelling. Request of national code. Reimbursement application.
- Cosmetics: Compliance assessment and notification of cosmetics products to competent authorities.
- Review of labelling. Request of national code.
- Food supplements: Compliance assessment and notification to competent authorities. Review of labelling. Request of national code.
- Other health products: Compliance assessment and notification to competent authorities. Review of labelling.
- Supporting on promotional material revision, transparency and notification (medicines/cosmetics/medical devices/food supplements).
- Electronic archive of regulatory affairs related documentation.
Your Profile
- Graduate degree in Pharmaceutical Sciences or others.
- At least 1 year experience
- Good knowledge of written and spoken English.
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.