International Regulatory Affairs Liaison (m/f/x)

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Date: 23-Oct-2020

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 cardiovascular diseases, under the Group’s 2025 vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology. Our European headquarters are in Munich, Germany and we have affiliates in 13 European countries including Denmark, where Copenhagen acts as the Nordic headquarter. For more information: www.daiichi-sankyo.eu.

 

 

For our headquarter in Munich we are seeking highly qualified candidates to fill the position of

 

International Regulatory Affairs Liaison (m/f/x)

 

 

Purpose of the function:

To provide International Regulatory Strategy support for assigned projects, products and non-project work. Provide support for Tier 2 and 3 country regulatory international submissions and filing strategies as well as marketing authorisation application reviews. Represent International Regulatory Affairs as assigned by the International Regulatory Affairs Liaison Lead working with the Global Regulatory Leads to become a fully recognised member of a multi-disciplinary global project team, providing expertise on international regulatory matters.

 

 

Role and Responsibilities:

  • Support Local/regional regulatory teams for assigned products for assessing regulatory landscape and regulations to optimise our regulatory strategies and submission plans and provide regulatory input into Development Strategy to enable timely commercial desirable registrations across the regions.
  • Advise global teams on specific local requirements or gaps in the global clinical development to support local submissions and collaborate to develop mitigation plans (e.g. bridging/sub-population requirements).
  • Champion for countries to obtain the needed global and regional resources (e.g. to participate in global registration-directed trials, to prepare bridging reports, to respond to health authority queries rapidly).
  • For assigned products work with Global and Local Regulatory Teams and communicate project specific information to local teams, ensuring alignment between registration/submission requirements and local development plans, support translation of global regulatory expectations into local plans and support the execution of these plans.
  • Keep current with, review and interpret international regulatory and scientific regulations and initiatives, communicate important changes and trends with the relevant stakeholders, making recommendations to senior management.
 

Personal skills and professional experience:

  • Bachelor degree in Life Science or Medical Science; Degree in Pharmacy, Master and/or PhD preferred; Master Degree in Regulatory Affairs is a plus
  • Minimum of 5 years of experience in global regulatory affairs with emphasis on International drug development and marketing authorisation applications in International Markets.
  • Experience of working in global environment.
  • Proven ability to plan, coordinate and lead submission activities simultaneously.                                              
  • Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation.
  • Ability to develop and maintain good relationships, gain the trust of others, challenge views and present and argue cases in a professional and respectful manner.
  • Solution and detail-oriented; well-organised and self-motivated.
  • Excellent written and oral communication skills in English, Spanish and/or French as a second language preferred

 

 

 

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 foward to hearing from you.