Global Head of Regulatory Affairs
February 2012 to Present
Head of Global QA and RA Europe
2009 to February 2012
Astion Pharma A/S
Vice President RA and QA
January 2006 to March 2009
Actavis Nordic A/S
Head of Nordic RA and QA
2002 to 2005
Aventis Pasteur MSD
Head of Nordic RA and QA
1998 to 2002
H. Lundbeck A/S
Regulatory Affairs Specialist
1993 to 1998
What company does Lene Rose Arfelt work for?
Lene Rose Arfelt works for Thrombogenics NV
What is Lene Rose Arfelt's role at Thrombogenics NV?
Lene Rose Arfelt is Global Head of Regulatory Affairs
What industry does Lene Rose Arfelt work in?
Lene Rose Arfelt works in the Biotechnology industry.
Extensive experience in Regulatory Affairs and Quality Assurance, Biologicals medicinal products, Small molecules medicinal products, Global pharmaceutical development, Marketing authorisation Applications (MAA) (Centralised Procedure, Mutual Recognition Procedures, National Procedures), Biologicals License Applications (BLA), Scientific Advices, Paediatric Development, Orphan designations, pre-IND meetings, pre-BLA/NDA meetings Health Authority dialogue and negotiations, Launch of several new products, People management, inspirations and processes , Larger pharma and SME pharma company experience, Licensing/Partner agreements, Member ship: executive development committees and development steering committees Document management systems, electronic CTD new marketing authorisation applications Regulatory expertise in development within ophthalmology, dermatology, vaccines, CNS, cardio-vascularGlobal Head of Regulatory Affairs @ From February 2012 to Present (3 years 6 months) BelgiumHead of Global QA and RA Europe @ From 2009 to February 2012 (3 years) BelgiumVice President RA and QA @ From January 2006 to March 2009 (3 years 3 months) Head of Nordic RA and QA @ From 2002 to 2005 (3 years) Head of Nordic RA and QA @ From 1998 to 2002 (4 years) Regulatory Affairs Specialist @ International Regulatory Affairs From 1993 to 1998 (5 years) M. Sc. pharm @ Danmarks Farmaceutiske Universitet From 1984 to 1990 Vestfyns Gymnasium Lene Rose Arfelt is skilled in: Quality Assurance, Regulatory Affairs, Biologics, Management, Vaccines, Product Development, Pharmaceutical Industry, Dermatology, Medicine, Biotechnology, Regulatory Submissions, eCTD, Clinical Development, FDA
Extraversion (E), Sensing (S), Feeling (F), Perceiving (P)
3 year(s), 7 month(s)
There's 70% chance that Lene Rose Arfelt is seeking for new opportunities
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