Director Regulatory Affairs (m/f)

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)
   

Interessiert?

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