For a leading bio-pharmaceutical company in Bavaria, we are currently looking for an Associate Director Regulatory Affairs (m/f/d). In this role, you will be responsible for both managing the regulatory affairs team of more than ten people and managing technically all regulatory-related projects and implement regulatory strategies. If you want to become part of a growing company with a great culture, we should get in contact.
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