Image of Lene Rose Arfelt

Lene Rose Arfelt

Global Head of Regulatory Affairs

Global Head of Regulatory Affairs Thrombogenics, Belgium

Antwerp Area, Belgium

Section title

Lene Rose Arfelt's Email Addresses & Phone Numbers

Lene Rose Arfelt's Work Experience

Thrombogenics NV

Global Head of Regulatory Affairs

February 2012 to Present

Belgium

Thrombogenics NV

Head of Global QA and RA Europe

2009 to February 2012

Belgium

Astion Pharma A/S

Vice President RA and QA

January 2006 to March 2009

Lene Rose Arfelt's Education

Danmarks Farmaceutiske Universitet

M. Sc. pharm

1984 to 1990

Vestfyns Gymnasium

Lene Rose Arfelt's Professional Skills Radar Chart

Based on our findings, Lene Rose Arfelt is ...

Innovative
Humanist
Critical

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Based on our findings, Lene Rose Arfelt is ...

21% Left Brained
79% Right Brained

Lene Rose Arfelt's Estimated Salary Range

About Lene Rose Arfelt's Current Company

Thrombogenics NV

Frequently Asked Questions about Lene Rose Arfelt

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 is Lene Rose Arfelt's personal email address?

Lene Rose Arfelt's personal email address is le****[email protected]


What is Lene Rose Arfelt's business email address?

Lene Rose Arfelt's business email address is l****[email protected]


What is Lene Rose Arfelt's Phone Number?

Lene Rose Arfelt's phone (**) *** *** 359


What industry does Lene Rose Arfelt work in?

Lene Rose Arfelt works in the Biotechnology industry.


Who are Lene Rose Arfelt's colleagues?

Lene Rose Arfelt's colleagues are Pam Schaneen, Claude Sander, Paul Willems, Patrik MD, Al Aronson, Greet Marynissen, Matthieu Bedoiseau, Julie Clark, Mathieu Peeters, and Alfred Aronson


About Lene Rose Arfelt

📖 Summary

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


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Lene Rose Arfelt's Personality Type

Extraversion (E), Sensing (S), Feeling (F), Perceiving (P)

Average Tenure

3 year(s), 7 month(s)

Lene Rose Arfelt's Willingness to Change Jobs

Unlikely

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