With over 120 years of experience and more than17,000 employees in over 20 countries, Daiichi Sankyo is dedicatedto discovering, developing, and delivering new standards of carethat enrich the quality of life around the world. In Europe, wefocus on two areas: The goal of our Specialty Business is toprotect people from cardiovascular disease, the leading cause ofdeath in Europe, and help patients who suffer from it to enjoyevery precious moment of life. In Oncology, we strive to become aglobal pharma innovator with competitive advantage, creating noveltherapies for people with cancer. Our European headquarters are inMunich, Germany, and we have affiliates in 13 European countriesand Canada.
For our headquarter in Munich we areseeking highly qualified candidates to fill the position:
Senior Manager Regulatory Affairs CMC(m/w/x)
Thefunction of EU Regulatory Affairs CMC:
Within Daiichi Sankyo`s Technology Unit, the role of theEU Regulatory Affairs CMC function is to lead the preparation ofdossiers of Daiichi Sankyo's development and commercial products,and to submit to EU and international health authorities. To ensurehigh quality standards and health authority expectations are met,we are both closely interacting with research and manufacturingfunctions within Daiichi Sankyo, and aiming to maintain a trustfulrelationship with health authorities, striving to ensure on-timeapproval of our drugs and securing patient supply.
The position:
The Senior Manager Regulatory Affairs CMC will provideEuropean regulatory CMC guidance and strategy for assigned productsand will represent Regulatory Affairs CMC EU in internal andexternal interactions (e.g. global and local project teams, workingteams, authorities communication (Scientific Advice), CMOs).He/She/It will lead the preparation of regulatory CMC documents forproducts of diverse modalities (small molecules, biologicalproducts or ATMPs) during development and/or commercial stage in amanner that is scientifically sound, commercially viable and inaccordance with current regulatory CMC standards. Further, it is agoal of the role to translate latest EU and internationalregulatory CMC requirements into state of the art, high-qualityregulatory CMC documentation, develop EU and internationalregulatory submission strategies, and review dossiers and technicaldocuments.
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