Job title: Associate Director Regulatory Affairs
Company: Ageneo Life Science Experts
Job description: We’re looking for a candidate to fill this position in an exciting company.
- You will develop and implement regulatory strategies from preclinics up to registration
- You will ensure compliance with applicable regulations in an international setting
- You will oversee the preparation of regulatory documents, protocols, etc.
- You will lead and coordinate submissions, INDs, CTAs, MAA/BLAs etc.
- You will coordinate and interface with legal authorities and support your team during the preparation and execution of meetings with FDA, EMA, and other regulatory agencies
- You will impact the regulatory strategies in different projects, development stages and settings
- You will manage CROs and other external partners
- You will interface with internal teams in order to develop and improve processes, ensuring the compliance throughout all process phases
- You will manage and develop your team and be their trainer and coach
- Degree in natural sciences (Master or PhD), ideally in biology, biotechnology, pharmaceutical sciences or comparable
- Profound knowledge and experience in regulatory CMC for biologics
- Many years of professional experience in a pharmaceutical resp. bio-pharmaceutical company
- At least five years of experience in a responsible role in regulatory affairs
- Thorough knowledge of the drug development process and experience with submission processes along different development phases
- Excellent communication and presentation skills
- Leadership experience and talent development experience is preferable
- Excellent English language skills
- Work permit for Germany is mandatory
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