Manager CMC Regulatory Affairs (m/f/x)

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Date: 05-Dec-2018

Location: Pfaffenhofen an der Ilm, Germany

Company: Daiichi Sankyo Europe

Affiliate: Daiichi Sankyo Europe GmbH

 

Passion for Innovation. Compassion for Patients.™

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, under the Group’s 2025 Vision 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 responsibilites:

  • 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.