Director Regulatory Affairs (m/f)

Deze procedure is gesloten (30-09-2009).
Zorg & welzijn
100k - 150k per annum
Hays AG

Hays is one of the world's leading personnel service providers, concentrating on the recruitment of specialists - whether for project work, for permanent positions or for temporary assignments. In Germany, Austria, and Switzerland, more than 600 top international companies rely on our quality-assured processes when they are looking for experts.

We are looking for a

Director Regulatory Affairs (m/f)

for a permanent position in Baden-Württemberg
Reference number: 97303/1

Your Duties:

  • Represent Regulatory Affairs in Global Project Teams.
  • Lead Regulatory Affairs sub-teams.
  • Manage the regulatory submission process through to approval, including management and coordination of the preparation of all regulatory documentation.
  • Manage the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes.
  • Prepare regulatory strategies for projects.
  • Review protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) including CTAs.
  • Decide on submission readiness.

Your Qualifications:

  • Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
  • Excellent spoken and written English and German
  • Experience in preparation and management of full submissions or large variations/supplements in at least 1 ICH region, through to authorization
  • Experience in leading regulatory agency interactions including management of the associated documentation and rehearsals
  • Experience in CTA requirements
  • Development and preparation of successful regulatory strategies
  • Management of and experience with maintenance activities in ICH region.
  • Experience in NBEs products.
  • Experience in working on early development projects (FIM)


Dann senden Sie Ihre Online-Bewerbung bitte direkt über folgenden Link.

Deze procedure is gesloten (30-09-2009).