Regulatory / Quality Affairs Manager Benelux

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Date: 28-Aug-2021

Location: Nationwide, Netherlands, 1014 BA

Company: Daiichi Sankyo Europe

Legal Entity: Daiichi Sankyo Nederland B.V.

 

Passion for Innovation. Compassion for Patients.™

Daiichi Sankyo is dedicated to creating new modalities and innovative medicines by leveraging our world-class science and technology for our purpose “to contribute to the enrichment of quality of life around the world.” In addition to our current portfolio of medicines for cancer and cardiovascular disease, Daiichi Sankyo is primarily focused on developing novel therapies for people with cancer as well as other diseases with high unmet medical needs. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation to realize our 2030 Vision to become an “Innovative Global Healthcare Company Contributing to the Sustainable Development of Society.”Our European headquarters are located in Munich, Germany and we have affiliates in 13 European countries. With about 2,000 employees, we are one of the strongest Japanese pharmaceutical companies in Europe.

 

For more information: www.daiichi-sankyo.nl

 

Regulatory and Quality Affairs Manager Benelux

Daiichi Sankyo Nederland B.V.

 

Context

The Regulatory and Quality Affairs Manager BeNeLux reports to the Medical Director, responsible for Medical Affairs CV Belgium and Regulatory Quality BeNeLux, based in Belgium (further down named MedDir).

The Regulator and Quality Affairs Manager BeNeLux is based in the Netherlands and works in tandem with the Regulatory and Quality Affairs Manager BeNeLux based in Belgium.

Both functions cover the Benelux region, working in close collaboration, in line with agreements made between both functions, MedDir and Country Managers the Netherlands and Belgium. Both functions are back-up for each other.

The Regulatory and Quality Affairs Manager implements compliance tasks specific to the Dutch environment, in close collaboration with the Legal and Compliance Manager BeNeLux. The Legal and Compliance Manager BeNeLux remains fully end responsible for the Legal & Compliance operations in BeNeLux.

 

 

Purpose of the job

 

The Regulatory and Quality Affairs Manager safeguards company’s product licenses, quality system and patients’ safety.  (S)he is responsible for all regulatory affairs related matters for products registered and marketed within Daiichi Sankyo Netherlands (DSNL), Belgium and Luxembourg (DSBE), in collaboration with Daiichi Sankyo Europe (DSE), as per the responsibility matrix. The Regulatory and Quality Affairs Manager is responsible for the Benelux Quality Management System, all aspects of Good Distribution Practices (GDP) and supports or leads GxP related audits with Subject Matter Experts, as per the responsibility matrix.The Regulatory and Quality Affairs Manager executes local compliance tasks for the Netherlands.

 

 

Results areas

  • Regulatory Affairs
  • Quality Management System
  • Good Distribution Practice
  • Operational Compliance (NL)

 

Skills & Qualities

  • Excellent language skills: Dutch and English is a must, French is a benefit
  • At least one year of experience in Quality management, including SOP management skills, AND/OR at least one year of experience in Regulatory Affairs
  • Strong personal integrity and ethics. Deep CGR knowledge.
  • Ability to communicate clearly and positively influence others at all levels of the organization
  • Proactively seek to understand the objectives of colleagues in order to translate that to functional solutions.
  • High self-sustainable problem-solving capacity
  • Process leadership skills
  • Successful experience in cross-functional collaboration and cross-border collaboration
  • Intercultural skill
  • Passion for innovation, processes, and compliance
  • Drive and motivation for self-development and learning, and to share knowledge and experience across the company