Associate Director Regulatory Affairs (m/f/d)

By | Februar 16, 2021
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Job title: Associate Director Regulatory Affairs (m/f/d)

Company: Ageneo Life Science Experts

Job description: Associate Director Regulatory Affairs (m/f/d) Jetzt bewerben DAS UNTERNEHMEN 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 ; IHRE AUFGABEN 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 IHR PROFIL 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 BENEFITS high impact role excellent work and company culture flexibility and additional social benefits Jetzt bewerben Ansprechpartner Dilsad Babayigit

Expected salary:

Location: Bayern

Job date: Tue, 16 Feb 2021 07:39:35 GMT

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