Senior Manager CMC Regulatory Affairs (m/f/x)
Jetzt bewerben »Datum: 01.07.2022
Standort: München, Deutschland, 81379
Unternehmen: Daiichi Sankyo Europe
Passion for Innovation. Compassion for Patients.
Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.
For our headquarter in Munich we are seeking highly qualified candidates to fill the position:
Senior Manager CMC Regulatory Affairs (m/f/x)
The position:
The Senior Manager Regulatory Affairs CMC will provide European regulatory CMC guidance and strategy for assigned products and will represent Regulatory Affairs CMC EU in internal and external interactions (e.g. global and local project teams, working teams, authorities interactions (Scientific Advice), CMOs). The function will support or lead the preparation of regulatory CMC documents during development and life cycle management in a manner that is scientifically sound, commercially viable and in accordance with regulatory CMC standards. He/She may act as a specialist for biological products in the EU regulatory CMC field. The function communicates EU and international regulatory requirements to authoring teams, develop the EU regulatory strategies and review dossiers and technical documents. The function and the team collaborates companywide within the global RACMC department and technical functions. The function is proactively influencing the internal, but also external regulatory affairs environment.
Personal skills and professional experience:
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What we offer
Working at Daiichi Sankyo
At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.