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Regulatory affairs team leader/ project manager
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Date de dernière mise à jour :

29 août 2013

Lieu :

CV :

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
Market: France

•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
•Complaints management
•Safety contact
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 HEALTH AND LAW (PROFESSIONAL MASTER DEGREE HOLDER): European Regulatory affairs and European health policies

Languages- Hobbies
Languages: French (mother tong) - English (intermediate plus) - German (basic level)
Hobbies: Running, Fitness, Theater, drawing

Remarques :

Regulatory affairs manager

7 years Experienced regulatory and pharmaceutical affairs pharmacist, team leader recognized to be creative, daring, polyvalent and open minded.
35 years
French nationality

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