Técnico de assuntos regulamentares

- Regulatory management of Marketing Authorization dossiers of Medicinal Products for Human Use – national, european and third countries markets (e.g Saudi Arabia, United Arab Emirates, Vietnam, Lebanon, etc.);
- Submission and follow-up of MA applications via national, MRP and DCP;
- Coordination of regulatory activities with authorities, plant and partners;
- Preparation of responses to Health Authority queries during regulatory procedures;
- Post-approval lifecycle management such as MA variations and renewals;
- MA applications regulatory strategy;
- Analysis /revision of technical documents (e.g quality documents from plant);
- eCTD and NeeS format compliance
- Artworks revision.

- Regulatory Affairs advice and support:
- Preparation, submission and follow-up of Marketing Authorization dossiers to the Regulatory Authority of Medicinal Products of Human Use (especially to national Competent Authority - Infarmed I.P and MHRA) (in NeeS and e-CTD format) (National Procedure, MRP or DCP, Portugal as Reference Member State or as Concerned Member State); 
- Preparation and submission of MA variations (by National Procedure, MRP or DCP); Preparation of MA Renewal; 
- Preparation and submission of Marketing Authorization Holder transfer application; 
- Consolidation of quality module of MA dossier; 
- Elaboration of Patient Information Leaflets Readability Tests Reports and Bridging Reports; 
- Update and maintenance of products’ portfolio/databases; 
- Technical translation of SPC, PIL and labeling and harmonization with current QRD template); 
- Pharmacovigilance activities (New MA registration, invalidations and updates in XEVMPD); 
- Batch releases.

- Preparation, submission and follow-up of Marketing Authorization dossiers to the Regulatory Authority of Medicinal Products of Human Use (Infarmed I.P) (in NeeS and e-CTD) (National Procedure, Mutual Recognition and Decentralized Procedures, Portugal as Reference Member State or Concerned Member State); 
- Preparation and submission of MA variations (according to the new regulation No. 1234/2008); 
- MA Renewal; 
- Preparation and submission of Marketing Authorization Holder transfer requests; 
- Preparation of Risk Management Plan; 
- Preparation of clinical and nonclinical reports (and addendum); 
- Price approval requests and reimbursement requests for generic/non-generic products; 
- Elaboration of Patient Information Leaflets readability tests reports and Bridging Reports; 
- Technical translation of SPC, PIL and labeling and harmonization with QRD template); 
- Pharmacovigilance activities (Preparation of PSUR, literature research and XEVMPD); 
- Cosmetics and food supplements registration to the Competent Authorities, etc.