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Sanofi Pasteur
- Regulatory Product Manager _ Registration in Japan
Lyon
2013 - maintenant
- Prepares and coordinates the creation of the complete license application for Japan
- Ensures preparation of the components of the submission within pre-defined schedules in accordance with relevant RA procedures, tools, and templates, and coordinates the final submissions to MHLW through Japanese Affiliates.
- Anticipates any delays in pre-defined submissions, finds the root cause, sets-up corrective action plan and/or proposes alternate solutions.
- Responsible for the notification and recommends the inclusion of the most appropriate individuals within the company based upon the criticality of the issues to be addressed.
- Discusses and may negotiate issues with regulatory authorities/third parties; and communicates, documents and archives information for the organization.
- Responsible for notification to relevant functional areas and impacted project team(s) regarding communications/feedback from regulatory authority.
- Sets up the necessary meetings with Japanese Affiliates and co-ordinates the preparation of the pre-reads and the presentations.
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Sanofi Pasteur
- Regulatory Product Manager for Rabies vaccines
Lyon
2012 - 2012
- Executes and implements the defined regulatory strategy via relevant submissions.
- Prepares and coordinates the creation of the complete license applications (registration, variation, renewal) and other regulatory submissions for regulatory authorities and/or third parties.
- Organizes the compilation of the entire submission.
- Ensures preparation of the components of the submission within pre-defined schedules in accordance with relevant RA procedures, tools, and templates, and coordinates the final submissions to regulatory authorities and/or to third parties.
- Anticipates any delays in pre-defined submissions, finds the root cause, sets-up corrective action plan and/or proposes alternate solutions.
- Responsible for the notification and recommends the inclusion of the most appropriate individuals within the company based upon the criticality of the issues to be addressed.
- Discusses and may negotiate issues with regulatory authorities/third parties; and communicates, documents and archives information for the organization.
- Responsible for notification to relevant functional areas and impacted project team(s) regarding communications/feedback from regulatory authority.
- Sets up the necessary meetings with regulatory authorities/third parties and co-ordinates the preparation of the pre-reads and the presentations.
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Sanofi Pasteur, Marcy L’Etoile (69)
- Business Processes & System (BPS) Leader
2011 - 2012
Business Processes & System (BPS) Leader for RA International department (divided in 3 Business Unites)
- Ensure definition and implementation of global processes and enforce them for BUs activities
- Prioritize the process related actions within the 3 BUs and participate to prioritization of cross functional actions
- Represent the BU function for development and decision related to global transversal processes and tools
- Represent the voice of the BUs function at the BPS committee and take decision related to process and systems for the function
- Contribute to the implementation of new processes, their training (at HQ or with affiliates), follow the implementation of new processes to verify their applicability
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Laboratoire Aguettant, Lyon (69),
- Trainee, in RA Department
2008 - 2008
-Writing of variation for France and Europe for injectable pharmaceutical products
-Submission of variation in France and follow-up with HA
-File reformating from NTA to CTD (modules 1,2 et 3)
-International registration : definition of RA requirements for registration in Singapore and Thailand
-Packaging validation
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Becton Dickinson_Medical_ Pharmaceutical system, Le Pont de Claix (38)
- Pharmacist_Regulatory Affairs Specialist
2008 - 2011
RA Specialist in primary packaging and medical device business for sterile and injectable pharmaceutical products
- RA representative in cross-functional teams linked to expertise skills
- Development of expertise skills on
•Sterilization (ETO, gamma, hot water)
•Sterile Barrier System
•Washing – depyrogenation
- Support to customers for regulatory advice and registration of their products at worldwide level
- Response to Health Authority questions directly or via customers (FDA, EMEA, Health Canada, KFDA…)
- Change Control Management – Definition of the change impact on files (DMF, TD, and Essential Requirements) and regulatory requirements
- Process development to improve RA activities
- Maintain the knowledge and awareness of current applicable regulations and standards for medical device and pharmaceutical products.
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Leem, Paris (75)
- Trainee in Clinical Research department
2007 - 2007
Participation in project teams with Leem_Afssaps_Pharmaceutical Industry representatives
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CHU Lapeyronie, Montpellier (34)
- Trainee in Hospital, Clinical Trial division in the pharmacy department
2007 - 2007
