29 août 2013
Professional experience – 7 years
Medium company – Headquarter,manufacturing site.
Since Jan. 2011
Regulatory affairs team Leader – Acting Qualified Person
Mission: Proposition and implementation of the regulatory strategy to ensure compliance with pharmaceutical regulation for the development and registration of products.
Portfolio: 15 OTC products leader- 477 references
Market: France, Belgium, Poland, Germany, Portugal, Italia, Spain , Tunisia, Russia, Vietnam, Brazil, Mexico, US
•Planning and coordination of registration activities for the whole portfolio in the due timelines.
•Management, leading and evaluation of the Regulatory Affairs team (7 persons).
•Top management reporting through the creation of dashboards and indicators follows up.
•Management and follow up of the departmental budget.
•Management of relationships with health authorities for registration and product life.
•Preparation or coordination of pharmaceutical or clinical expertises.
•Participation in the industrial and analytical development conducted for MA dossiers.
•Coordination of validation testing processes or analytical methods.
•Acting qualified person and Qualified person for Safety
Small Laboratory – MA Holder
May 2009/Dec. 2010
Pharmaceutical affairs project manager
Mission: Management of regulatory affairs and pharmaceutical regulation.
Portfolio: 3 RX drugs – Therapeutic area: Muscle relaxant and anti vertigo
•Performance of CMC due diligences
•CTD update for improvement of MA dossier quality
•Management of Quality documentation
•Performance of subcontractor audits (manufacturers)
•Permanent contact for safety and medical information
Big generics company – French branch
June 2007/ June 2009 (2 years)
Regulatory affairs CMC project manager
Mission: Submission of variation to improve industrial flow, new application to enlarge portfolio and maintenance of MA.
Portfolio: 52 RX and OTC generic drugs (oral tablets / topic liquids)
Market: France, Germany, Poland, UK, Spain
•Post MA variations (industrial optimisation), line extension (new galenic form), API’ sourcing registration.
•New submissions (central, Mutual Recognition and national procedures)
•CMC part due diligence: in collaboration with IBD department, check of the DMF before purchase
•Advertising control: legal mentions
•Packaging article validation: Re-Branding phases for the switch Merck generic/ Mylan
•Readability patient information leaflets project manager: tender offer, timetable, information collection, cost strategy.
•Subsidiaries contact and Health Authorities contact (AFSSAPS, MHRA, EMEA)
French Health Authority
Feb. 2007/ Jun. 2007
Technical and regulatory evaluator
•Data base check
•Regulatory recommendation redaction
•Standard Operating procedure redaction
Big pharma company - French branch
May 2007/ Jan. 2007
Quality Assurance Pharmacist (5 months)
•Quality Assurance documentation management
Last year professional master degree project (5 months)
•Post marketing Authorisation clinical variation: Therapeutic areas: Diabetes/ Infectious diseases/ Cardiology/ Thrombosis
•Clinical Trial amendment
•Packaging article control
UNIVERSITY OF PHARMACY (STATE DOCTORATE OF PHARMACY HOLDER): Doctorate thesis
UNIVERSITY OF HEALTH AND LAW (PROFESSIONAL MASTER DEGREE HOLDER): European Regulatory affairs and European health policies
Languages: French (mother tong) - English (intermediate plus) - German (basic level)
Hobbies: Running, Fitness, Theater, drawing
Regulatory affairs manager
7 years Experienced regulatory and pharmaceutical affairs pharmacist, team leader recognized to be creative, daring, polyvalent and open minded.
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