Sector Experience
Healthcare
Life Sciences & Pharma
Languages
English
Portuguese
6
years
Years of Experience
1/20
Member Since
Experience
GlaxoSmithKline
Operations
Compliance Associate
• Supported maintenance of role-based curricula and planning for instructor-led training sessions
• Assisted in lifecycle management of Medical and RDO Divisional Standard Operating Procedures (SOPs) and guidance documents to meet corporate requirements
• Assisted Manager with risk management activities
• Supported business systems project managers with systems and operational excellence
• Assisted in Audit & Inspection readiness activities including compliance monitoring
• Assisted in lifecycle management of Medical and RDO Divisional Standard Operating Procedures (SOPs) and guidance documents to meet corporate requirements
• Assisted Manager with risk management activities
• Supported business systems project managers with systems and operational excellence
• Assisted in Audit & Inspection readiness activities including compliance monitoring
Teva Pharmaceutical
Operations
Project Lead
Successfully managed a project in record time with the objective of maintaining the market share of the company's extensive product line. The project consisted in implementing new packaging in a great line of products, for private sale of the largest network of pharmacies in Canada. The company and its competitors vied for the sale that would be given the first company to implement the new packaging.
Apotex Inc.
Other
Senior Regulatory Affairs Associate
Prepared product submissions to the US, Canada, Europe, Asia and Latin America, complying with the regulatory requirements of each country, as well as with pre-defined goals and deadlines by the company.
Merck KGaA
Other
Regulatory Affairs Associate
• Coordinated regulatory requirements of markets in Latin America, with the Regulatory Affairs Departments in companies’ subsidiaries/partners of Latin America, to negotiate technical requirements and deadlines;
• Prepared ANDA and ANDS submissions, to Health Canada and FDA respectively, in e- CTD format, complying with pre-defined goals and deadlines by the company and by its regulatory agency.
• Prepared ANDA and ANDS submissions, to Health Canada and FDA respectively, in e- CTD format, complying with pre-defined goals and deadlines by the company and by its regulatory agency.
Merck KGaA
Other
Bioequivalence Lead
Responsible for conducting, responding to regulatory questions, and approving bioequivalence studies for generic drug registration.