Marielle Mouque-Peltier
Regulatory Affairs Cmc @Sanofi
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WORK HISTORY
Regulatory Affairs Cmc @Sanofi
Région de Lyon, FR
In charge of a Biological product THYMOGLOBULINE registered in 64 countries - Management of regulatory CMC aspects of the product through all phases of life-cycle of the product- Maintenance of Mas in compliance with current regulation : variations, renewals - Review and evaluation of chemistry, manufacturing and controls information in currently approved marketing applications, supplements, variations, renewals, annual reports, production batch documentation, technical reports, standard operating procedures - Review and/ or prepariation of the CMC document packages for regulatory submissions. This includes initial submission to Health Authorities(HAs) and preparation of responses to questions from HAs balancing HA requirements and corporate objectives- Provide regulatory support for manufacturing & testing operations and to technical support groups- Review technical documentation (Project Plans, Change Control, Deviations, CAPA)- Recommends/approves changes as appropriate to ensure regulatory compliance and conformances with existing regulatory approvals - Provide support for site regulatory inspections - Ability to represent the department on project teams - Research and analyze regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes. Performs regulatory review, assessment, and approval of change controls, SOP’s, CAPA’s.
EDUCATION
Chatenay-Malabry faculty
Pharmacist Doctorate Diploma, Industrial option
Sceaux faculty
DESS "Health law"
ABOUT MARIELLE MOUQUE-PELTIER
Project management : due diligence & regulatory strategy Planning, reviewing & submission of EU MA applications (NAT, MRP, DCP, CP) Extensive CMC experience (Module 3, Module 2.3 & pharmaceutical variations), pharmaceutical expertise Preparation of Module 1 including management of SPCs, patient leaflets, labels and leaflet user testing Preparation of responses following file assessment Post-approval activity - Prices/Reimbursment - Validation of advertising materials & communication - Packaging establishment and checking of their conformity with the regulation in force - Pharmaceutical Variations, manufacturing switches, renewals- Variation files to change the product information (DMI) Direct contact with EU regulatory authorities Quality assurance (writing SOPs, technical agreements with the manufacturers
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