Regulatory affairs manager

Coordinate small molecules. Biological, medical devices and food life cycle, regulatory maintenance and Initial Marketing application, preparation of leaflet texts and packaging materials in accordance with internal standard and legislations in force and evaluation of promotional materials. Participation in trade association meeting to deeply discuss impacts of new regulations. 
Analysis of regulatory viability and strategies to register new drugs in the country and to prune and/or de-register a drug and/or brand. Assessment of post-approval variations in accordance to current regulation. Monitoring of IMA’s competitors.
Legal documents, good manufacturing practices certification.
Coordinate Compliance activities related to Regulatory Affairs such as procedures revision, CAPA implementation and process improvement. Focal point and coordinator of internal and external audits.
Leadership and development of careers.

Biological, synthetic and medical device license application, life cycle and regulatory maintenance. Electronic application for new drugs. Application for Good Manufacturing Practices certification. Preparation of leaflet texts and packaging materials in accordance with internal standards and legislations in force. Evaluation of promotional materials. Participation in trade association meeting to discuss impacts of new regulations. Analysis of drug clinical development dossier. Assessment of post-approval variations according to the regulation. Harmonization with Internal Global Policies and creation of standard operational procedure for the department.

Biological, synthetic and medical device license application, life cycle and regulatory maintenance. Electronic application for new drugs. Application for Good Manufacturing Practices certification. Preparation of leaflet texts and packaging materials in accordance with internal standards and legislations in force. Evaluation of promotional materials. Participation in trade association meeting to discuss impacts of new regulations. Analysis of drug clinical development dossier. Assessment of post-approval variations according to the regulation. Harmonization with Internal Global Policies and creation of standard operational procedure for the department.

Biological license application, life cycle and regulatory maintenance. Application for Good Manufacturing Practices certification. Monitoring of publications in the Official Gazette. Monitoring of BLA’s competitors. Preparation of leaflet texts and packaging materials in accordance with internal standards and legislations in force. Evaluation of promotional materials. Participation in trade association meeting (Sindusfarma) to deeply discuss impacts of new regulations.

License application (synthetic – generics, similar and specific medication, medical advices, food), life cycle and regulatory maintenance. Post registration submissions, technical report analysis, monitoring of public consultations, new regulations. Review and approval of packaging material, leaflet texts and promotional materials in accordance with legislations in force. Participation in trade association meeting (Sindusfarma) to deeply discuss impacts of new regulations. Maintenance of Company’s administrative licenses.

Biological license application (vaccines and hyperimmune sera), life cycle and regulatory maintenance. Post registration submissions, technical report analysis, monitoring of public consultations, new regulations. Change controls evaluation. Review and approval of packaging material, leaflet texts and institutional materials in accordance with legislations in force. License application through Partnership for Productive Development for inclusion of vaccines in the National Immunization Program of Brazilian Ministry of Health.

Post-graduation

Graduation