Manager CMC Regulatory Affairs (m/f/x)

85276 Hettenshausen, 85276 Pfaffenhofen a.d. Ilm, 80331 München
11.01.2019

Daten dieser Anzeige

Job-ID: 009426151
Manager CMC Regulatory Affairs (m/f/x)

Daiichi Sankyo Europe GmbH

Germany

https://jobs.daiichi-sankyo.eu/job/Pfaffenhofen-an-der-Ilm-Manager-CMC-Regulatory-Affairs-%28mfx%29/506365201/

Leading the preparation of the assigned CMC regulatory documents Guiding, developing and overseeing the implementation of regulatory CMC strategy (Drug Substance and Drug Product) ensuring high quality of regulatory CMC documents Preparation of IMPDs, Briefing Books, Module 3 and responses to Health Authorities' CMC queries Providing accurate regulatory assessments of CMC post-approval changes and executing regulatory planning and implementation considering current guidelines Making significant contributions to drug development, manufacturing and commercialization through advanced regulatory EU expertise

Passion for Innovation. Compassion for Patients.(TM) Daiichi Sankyo and its 15.000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharma­ceutical products. In addition to a strong portfolio of medicines for hypertension and thrombotic disorders, the Group's 2025 vision is to become a «Global Pharma Innovator with Competitive Advantage in Oncology». Our European headquarters are in Munich, Germany and we have affiliates in 12 European countries. For more information: www.daiichi-sankyo.eu. For the metropolitan region Munich we are seeking highly qualified candidates to fill the position: Manager CMC Regulatory Affairs (m/f/x) As a member of the Pharmaceutical Development team, the main focus will be care of CMC Regulatory Affairs related activities in the field of Daiichi Sankyo´s product development, working in close cooperation with interdisciplinary project teams and the entire Development functions. Key responsibilities: Leading the preparation of the assigned CMC regulatory documents Guiding, developing and overseeing the implementation of regulatory CMC strategy (Drug Substance and Drug Product) ensuring high quality of regulatory CMC documents Preparation of IMPDs, Briefing Books, Module 3 and responses to Health Authorities' CMC queries Providing accurate regulatory assessments of CMC post-approval changes and executing regulatory planning and implementation considering current guidelines Making significant contributions to drug development, manufacturing and commercialization through advanced regulatory EU expertise Requirements: Degree in Pharmacy 5+ years professional working experience in CMC Regulatory Affairs, in the development of biologics and/or small molecules Knowledge of drug development (Drug Substance and Drug Product) and knowledge of multidisciplinary functions involved in drug development, manufacturing, commercialization and product lifecycle management Results and goal oriented Excellent communication skills, both in English and German What we offer: We offer an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth. Please apply online at our Career Portal. We are looking forward to your application.  

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Vollzeit

85276 Hettenshausen

85276 Pfaffenhofen a.d. Ilm

80331 München