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RB Pharmaceuticals
- EU Regulatory Affairs Director
2011 - maintenant
Responsible for the Regulatory strategy in Europe and manage all the related activities including publishing and submission to Regulatory authorities within the area, maintenance and renewal of the Marketing Authorisations (centralised, decentralised/MRP and National), contracts with vendors. Face the external and internal auditors and representatives of National or International agencies.
Provide support to Pharmacovigilance, Medical Information, Health Policy and Commercial within EU and assess the compliance to the regulation (member of the EU Compliance Board).
Responsible for assessing the structure and processes in EU and member of the Global Regulatory team assessing Global processes
Member of the Core EU Leader Team in charge of defining the strategy and assessing implementation and follow-up, attend to all Regional Business reviews.
Member of Global Due Diligence team for acquisition (business or product) and in-licensing.
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RB Pharmaceuticals
- Deputy Qualified Person France
2011 - maintenant
Set up Quality Assurance, integrate Local SOP within the Global QA system.
AFSSaPS/ANSM opening audit: successfully passed
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Hospira
- Quallity manager
Meudon
2008 - 2011
In my current role I have had overall responsibility for:
- formulation and stability assessment of the named patient products (more than fifty TPN formulations per day),
- monitoring the Production units,
- batch release (from three hundred fifty to five hundred batches per day),
- assessing compliance,
- processing of deviations,
- investigations,
- corrective and preventive actions (CAPA),
- change management,
- training and accreditations of hundred and fifty persons,
- documentation control, internal audits and validation.
Harmonise the processes on the two sites (Birmingham and London).
Set-up tools for valuating processes and adequate resources.
Member of the management team on the sites.
Key achievements
Co lead the culture change in the two sites
Successful MHRA audit.
Set up streamlined daily requalification of the Production Units before the Production resumes.
Develop Technicians acknowledged for their technical skills as Team Leaders trusted by the other managers and their team through training and coaching and empower them.
Full compliance to the training program.
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Hospira
- Production Manager
Meudon
2008 - 2008
Head of Production team (120 people) manufacturing aseptically named patient injectable unlicensed medicines according to the “Specials” license granted by the MHRA (Medicines and Healthcare products Regulatory Agency). The lead time between order and the dispatch is three days for the anticancer, antibiotic and pain killer products but only few hours (four to seven hours) for the Total Parenteral Nutrition (TPN).
Review the Production processes for improving compliance to GxP.
Set up cross Unit training as employees’ development and improving flexibility and efficiency of the site.
Create communication with Commercial for anticipating Customers’ needs and wishes.
Member of the management team on the site.
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Mayne Pharma
- European Compounding Business Manager
2005 - 2008
Value potential roll out the expertise acquired in the United-Kingdom on the European continent.
Meet decision takers at Ministry of health in Spain, Italy and France.
Meet key opinion leaders in Denmark, Germany, Italy, France and Spain.
Pricing strategy agreed with Country managers and manufacturing site.
Identify potential partners.
Key achievements
First sales in two countries from the English site.
Confidentiality agreements signed with potential partners in France and Spain.
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Mayne Pharma
- Director Market Development, Middle Europe
2004 - 2005
Meet key opinion leaders in Germany, Italy and France for understanding their use of our licensed products (current or under development).
Work with BD team for defining specifications of identified added value presentations.
Meet potential partners (support of global Business Development team).
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Mayne
- Country manager
2003 - 2004
Negotiation of Reimbursement prices in front CEPS (Comité Economique des Produits de Santé), meetings with the Chairman.
Responsible for the budget.
Set up management team including Marketing, Finances, Sales and Regulatory.
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Mayne
- Marketing manager
1998 - 2003
Recruitment and daily management of Sales force.
Responsible for the budget (preparation and monthly reporting).
Marketing and sales plans.
Lead the global project of the first CE marked medical device involving manufacturing sites, supply chain, national marketing and regulatory affairs teams.
Key achievements
Fulfilment of all the budgets.
Success full launching of products.
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F.H. Faulding Pharmaceuticals - Mayne
- Qualified Person - Pharmacien responsable or Deputy
1997 - 2008
Key activities:
Set up the Company as Pharmaceutical company (set up of Quality Management System).
Prepare and manage the follow up of the Opening audit (2000) and standard audits.
Regulatory activities including:
- Submission of the applications and variations for injectable medicines,
- Submission of renewals,
- Support of the European Regulatory team.
Artworks for all the medicines and devices (carton, label, leaflet) and copy approval procedure for all the documentation available to patients and healthcare people.
Communication with manufacturing site and global supply chain to get the products timely.
Reimbursement prices negotiation in front CEPS (Comité Economique des Produits de Santé) and appeal.
Communication with Marketing, Sales and Finances for the preparation to successful launching and change further to approved variations.
Pharmacovigilance activities including:
- Report of the notified cases to AFSSaPS (Agence Française de Sécurité Sanitaire des Produits de Sante) and Corporate,
- Negotiate the calendar of the PSURs,
- Tracking and review of the PSURs before submission,
Batch documentation, Audit of the contracted distributor, Pharmacovigilance, Batch recalls.
Key achievements:
Successful AFSSaPS audits.
First CE mark of the Company (sterile device, site in the United States of America).
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F.H. Faulding Pharmaceuticals
- Technical manager
1996 - 1998
Key activities
Introduce the Company to AFSSaPS.
Trained as Qualified Person (Applied Analysis Limited, Beverley, United-Kingdom).
Part of the team negotiating Joint Venture.
Meet potential partners (out licensing) as support of the global BD team.
Submit application for controlled drug (successful).
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Fondation Hopital Saint-Joseph Paris
- Deputy Head Pharmacy Department
1993 - 1995
Therapeutic committee, Daily delivery named patient prescriptions, Clinical trials, Medical devices and medicines supply, sterilisation.
Train pharmacist residents and pharmacist students.
Responsible for the tenders covering the medicines and devices.
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Fondation Hopital Saint-Joseph Paris
- Pharmacist Anticancer Compounding
1987 - 1992
Key activities:
Set up the first compounding unit for anticancer in France.
Validate the disinfection using per acetic acid.
Writing the SOPs including training program.
Coumpounding software (from prescription to pharmacy back to Oncology unit).
Called by Head of the Oncology Unit for being member of the Oncology care management group.
Key achievements:
Cancer Patients’ smiles and trust.
Develop my successor individually called by Head of Oncology Unit for being member of the Oncology care management group.
Software rights given to Hospital pharmacist Associations, about 100 hospitals used it, more than 150 copies of the SOPs required by Hospital pharmacists in France and Europe.
Hospital pharmacy Dubernard Award for the work for the set up of the first anticancer compounding unit and its quality assurance program granted by the University hospital pharmacists and handed by Head of Cabinet of Ministry of Health.
