Head of EU CMC Regulatory Affairs (m/f/x)

Apply now »

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:

 

Head of EU CMC Regulatory Affairs (m/f/x)

 

Reporting to the Vice President Pharmaceutical Development Europe, the person will be accountable for the EU CMC RA related activities in the field of Daiichi Sankyo´s product development, working in close cooperation with the other regional heads (CMC Planning, Formulation Technology, Analytical Department and the further development function).

 

Key responsibilities:

  • Strategic and operational lead of the European Regulatory Affairs CMC (RACMC) Department within Pharmaceutical Development Europe
  • Accountability for securing the delivery of the CMC regulatory milestones of the EU development portfolio in-time including assessment of the probability of regulatory success together with risk mitigation measures
  • Close collaboration with other regional CMC heads and dotted line reporting to the global RACMC head to establish and align global processes and submission strategies / dossiers. Ensuring that these processes are understood and adhered to
  • Driving adequate surveillance of the EU CMC-related regulatory affairs environment and securing that such changes in regulatory environment are appropriately considered for the in-house RACMC strategy
  • Line Management and Mentoring for the assigned group of Regulatory Affairs CMC Managers

 

Profile:

  • Degree in Life Sciences (Pharmacy or similar); preferably Ph.D., Pharm D, or equivalent scientific degree
  • 8+ years professional working experience in cross-functional CMC development, preferably CMC Regulatory Affairs, with a proven track record in development and submission of various new biologics and small molecules
  • Routine in interaction with EU health authories and a strong network to the EU regulatory community
  • Strong knowledge of drug development (Drug Substance and Drug Product) and of the multidisciplinary functions involved in drug development, manufacturing, commercialization and product lifecycle management
  • Excellent in oral and written communication skills, both in English and German
  • Strong management and leadership skills

 

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.