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Sanofi Pasteur
- Global Regulatory Affairs Manager, CMC
Lyon
2011 - maintenant
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Sanofi Pasteur Limited (Toronto Canada)
- Regulatory Affairs Manager
2009 - 2010
- Assisted in development of regulatory strategies for multiple products,
- Prepared and reviewed submissions (paper, NEES, CTD, eCTD) including responses to questions for various health agencies worldwide (FDA, Health Canada, EMEA, TGA…),
- Managed the interactions and negociations with government health agencies worldwide to ensure prompt regulatory approbal,
- Developed labeling and packaging text content and conducted evaluation with regards to accuracy, scientific and clinical appropriateness and regulatory requirements,
- Coordinated contributions to labeling and packaging text contents from internal expert functions (Pharmacovigilance, Medical Affairs, Marketing, Clinical, Industrial Operations, Global Labeling),
- Reviewed promotional materials complying with corporate and government requirements and compiled documentation for new product registration,
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Sanofi Pasteur (France)
- Intern Regulatory Affairs
2008 - 2008
- Contributed to the development of internal processes to improve efficiency for responding to Periodic Safety Update Reports (PSURs) changes,
- Created a database of labeling clinical trials regulatory requirements,
- Created detailed database summarizing information in Company Core Data Sheet (CCDS) across multiple products,
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Villefranch Hospital (France)
- Intern at the pharmacy hospital (6 months)
2007 - 2008
- Rotations included Palliative care, Oncology, Rheumatology, Sterilisation,
- Assessed responses to a tender on Low Molecular Weight Heparin (LMWH),
- Answered phone calls from internal customers (the different units of the hospital) and external customers(pharmaceutical companies, sales representative) and archived their requests with our answers.
- Assisted in resolution of deficiencies in the Villefranche prison pharmacy, following an inspection of the Health Authorities (ensured compliance with regulations and quality assurance of the pharmaceutical activities, developed and implemented a method to control drug delivery, established a system for documenting, and securing the safety of drugs),
- Conducted a study of the introduction of new drugs under Temporary Authorization of Use (TAU) and drafted internal procedures to facilitate use of these drugs,
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Junior Pharma Industrie Lyon (JPIL)
- Co-founder and Vice-president
2007 - 2008
Junior-Oriented Company, nonprofit association with educational and economic goal.
- Managed a team of 10-12 people
- Developed and implemented internal status, organization, processes and templates.
- Created brochures for sponsorship.
- Organized a team building weekend for 70 students (secured funding and sponsorship for the event,contributed to the creation of event promotional materials).
- Mailing and phoning our partners to maintain relationships.
- Participated to the recruitment and training of new members.
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Community pharmacies
- Student Pharmacist
2002 - 2008
- Confirmed prescription for proper dosage,
- Dispensed prescribed pharmaceuticals to customers and advised them on the indications, contra-indications, adverse events, interactions and proper dosage,
- Advised customers on selection and use of non-prescription medications,
- Maintained and ordered stock for pharmaceutical supplies,
- Maintained medication profiles of customers including registry of controlled drugs, poisons and narcotic,
