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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.