Description
We are looking for a
Regulatory Affairs Manager (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Place: in Hesse
Branch: Wettbewerber
Your tasks:
- Preparation of regulatory documentation and management of regulatory submissions in the ICH regions and international regions in cooperation with an external vendor
- Close cooperation with the headquarter and country regulatory affairs functions in Europe and countries worldwide
Your qualifications
- Degree in Life Sciences or a related discipline, higher degree preferable (e.g. PhD, MSc, MBA)
- Fluent in spoken and written English
- Good interpersonal, team work and project management skills
- Attention to detail
- Ability to work in multi-cultural and cross-functional teams
- Strong goal- and solution-orientation combined with responsibility, initiative and perseverance
- Profound regulatory experience
- Experience in preparation and submission of dossiers in at least one ICH region, the preparation of documents for regulatory agency interactions, regulatory maintenance activities for authorisations in a local affiliate or head office and as a member in project teams
- Experience in Regulatory Affairs in international markets
- Project Management experience
Skills:
- Regulatory affairs manager