-
Ipsen
Boulogne-Billancourt
maintenant
-
D&A PHARMA
- Director Regulatory Affairs - Strategy and Clinical Development
2009 - maintenant
Start -up company developing compounds in the CNS for unmet medical needs (pain, addictions) in Europe & USA.
• Together with CEO, CFO, VP R&D and Clinical Development, elaborated strategy and budgets for product development and licensing
•Prepared Briefing Packages and conducted consultations (Scientific Advice, pre-IND) with agencies (EMA, FDA)
•With experts, defined the nature of the clinical program, the design of studies, the role of compassionate schemes
-
Self Employed
- Independent Regulatory Consultant
2009 - 2010
• provided advice on development and filing, most notably for a cancer vaccine, chronic hepatitis C, contraception.
•prepared effective documents for filing and interfaced with authorities and clients to manage MRP/DCP dossiers.
•presented ad-hoc analysis specific to products/ situations (ATMPs, compassionate use,accelerated assessment, compliance..)
•adviced clients on the transition to eCTD (strategy, selection, implementation or outsourcing) .
-
Almirall,R&D headquarters - Barcelona (Spain)
- Senior Regulatory Affairs Manager
2008 - 2009
The largest Spanish pharmaceutical company aiming to reinforce and strengthen its international presence via innovation in R&D and partnering.
Responsible for the regulatory strategy of products in development in asthma/COPD or going through key post marketing steps in pain, with a strong emphasis on paediatrics.
• devised with teams and management EU-US strategy for pipeline compounds or combinations in asthma/ COPD.
• monitored current and developing regulations, analyzing their impact on product or operations,with a major focus on EU /US
• prepared European CTAs or line extensions (variations, OTC switch...) coordinating their presentation and the annual budget
• contributed to strategic decisions, and elaborated pediatric dossiers to EMEA, FDA
-
PPD International, siège européen (Cambridge, Angleterre)
- Regulatory Affairs Consultant at PPD, European headquarters - Cambridge (UK),
2007 - 2008
At a time of strong growth for PPD Europe (present in 33 countries with over 10,500 professionals worldwide), I
• provided advice and support to international clients on strategic or technical European regulatory matters (from development to registration)
• wrote or conducted critical reviews of varied scientific documents for clinical trials and marketing authorizations.
• working to tight deadlines, coordinated submissions for clinical trials (CTAs) and MAAs, interfacing with project teams, clients and authorities. Controlled timelines and budget
• European leader, I collaborated with US colleagues, for the implementation of eCTD capabilities and service offers
-
Beaufour-Ipsen, R&D headquarters, London and Paris
- Director Regulatory Operations and Process Coordinationation
2004 - 2007
Ipsen is dynamic mid-size speciality pharmaceutical company focussed on the development of innovative products for hormone-dependent diseases.
Througouth this period, its turned from its European roots into a truly international group (~4000 people worldwide).
With a regulatory and company knowledge, I interfaced in various positions, in order to integrate regulatory requirements from early development and to improve therefore efficacy in dossier’s preparation or management.
I created the Regulatory Operations Unit (3 staff) in London and led its development in France in parallel with the integration systems and processes across R&D (10 sites, 5 countries, 300 users) and affiliates.
• investigated gains or risks in the implementation of global solutions in response to new legislations & internationalisation.
• elaborated strategic recommendations & project planning.
• constantly mediated between management, informatics & providers.
• led the e-CTD tool selection process & implementation.
-
Beaufour-Ipsen, London (UK), R&D Headquarters
- Regulatory Project Leader
2002 - 2004
Coordinated between headquarters, R&D functions, informatics & providers the definition /
implementation of new clinical or regulatory systems.
• provided expertise on global submissions requirements (content/format).
• business leader in document/publishing syst. implementation & upgrade.
• formalised business needs, reviewed technical & functional specifications.
• developed training or educational support across functional areas
-
Beaufour-Ipsen, R&D headquarters, London (UK)
- Regulatory Affairs Associate
1998 - 2002
Elaborated, together with international project teams and management, strategies and dossiers for product development and registration in new markets (UK, Ireland, Scandinavia, Australia, NZ, USA).
Responsible for a range of products either in development or marketed in the endocrinology and oncology areas.
Drove projects from early development, submission planning to regulatory, price and reimbursement approvals
• led the 1st preparation & simultaneous MAA submission across Europe.
• planned and submitted global dossiers (6 MAAs obtained) & responses.
• prepared and coordinated variations, PSURs, labelling change, renewals.
• justified company's position to regulatory authorities
-
Eli Lilly, European Headquarters-Brussels (Belgium)
- Regulatory Affairs Officer
1998 - 1998
Contributed to the harmonisation and optimization of the labeling from a key medicine (fluoxetine,Prozac), and participated to responses to authorities concerns
