Senior Manager Regulatory Affairs (m/f/x)

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Date: 11-Feb-2019

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, the Group’s 2025 vision is 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:

 

 

Senior Manager Regulatory Affairs (m/f/x)

 

The position:

The Senior Manager Regulatory Affairs will provide European regulatory guidance and strategy for assigned products and will represent Regulatory Affairs in internal and external interactions (e.g. project teams, working teams, authorities, affiliates, partners).

He/She will support or lead the preparation of regulatory documents and submissions during development and life cycle management in a manner that is scientifically sound, commercially viable and in accordance with regulatory standards. He/She may act as a specialist with regard to specific field of regulatory or therapeutic knowledge.
 

Key responsibilities:

Provide regulatory guidance and strategy with focus on development and life cycle management

  • To represent the Regulatory Affairs Function in cross-functional global development teams and to provide regulatory guidance and strategy for assigned projects and products
  • To plan, lead and manage regulatory submissions during development and life cycle management for assigned products in Europe
  • Guide and coordinate regulatory submissions in non-European countries in close collaboration with the global development team and the regions
  • To act as regulatory contact person for authorities, external partners and in-house functions
  • To keep current with the regulatory and scientific environment and support the creation of Standard Operating Procedures

 

Professional experience and personal skills:

  • Bachelor degree in Life Science or Medical Science, Master or PhD preferred; Masters Degree in Regulatory Affairs is a plus
  • Post-doctorate or professional experience in pre-clinical or clinical trials is a plus
  • Minimum of 5 years experience in the pharmaceutical industry with 3-5 years direct regulatory affairs experience with emphasis on drug development and marketing authorization applications in Europe and other global markets
  • Experience with pediatric clinical development and/or interactions with PDCO is a plus
  • Working knowledge of laws, regulations and guidelines is essential
  • Experience of working in a global, international regulatory environment and experience in the therapeutic area of CVM are desired
  • Understanding of drug development and regulatory processes
  • Ability to interact effectively with National Agencies and EMA
  • Ability to provide technical input, proven ability to plan, coordinate and lead activities simultaneously on multiple projects
  • Excellent interpersonal skills; ability to work across functions in a multinational organization to accomplish results
  • Detail-oriented; well organized and self-motivated; high ethical behavior
  • Excellent written and oral communication skills in English, 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.