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

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Date: 09-Nov-2018

Location: Munich, Germany, 81379

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 our European headquarters in Munich we are seeking highly qualified candidates to fill the position:

 

 

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

 

 

Key responsibilities:

  • Develops and implements the strategy for EU Regulatory Affairs Oncology, serves as the subject matter expert in European Regulatory strategy for Oncology
  • Accountable for the creation of robust CE Portfolio European regulatory strategies and tactics
  • Responsible for implementing and overseeing strategy, activities and compliance to achieve successful submissions and approvals in the Europe
  • Leads the European strategic planning and establishment of CE project European regulatory goals
  • Manages internal and external relationships and acts as a lead representative with European regulatory authorities
  • Continuously builds European team capability through high quality talent selection, mentoring and providing feedback, coaching, and professional development

 

 

Profile:

  • Master Degree or PHD in chemistry, biology, pharmacy or other related discipline or equivalent
  • Min. 15 years relevant professional experience in the pharmaceutical industry (min. 7 years in regulatory affairs)
  • Substantial late stage Oncology submission and approval experience in Europe (min. 5 years)
  • Min. 7 year leadership experience in an international environment
  • Documented ability to network and engage with senior oncology regulatory officials in Europe
  • Thorough understanding of oncology drug development (MAAs/CTAs) through market launch
  • Proven ability to lead, inspire, develop, coach and influence a team of direct and indirect reports in Regulatory Affairs
  • Demonstrated (matrix) leadership skills
  • Strategic and analytical abilities, diplomacy, negotiation and excellent oral and written communications skills
  • Business Fluent 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.