Regulatory Affairs Associate - EU Regulatory Procedural Management (m/f/x)

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Datum: 09.01.2021

Standort: München, Deutschland, 8

Unternehmen: Daiichi Sankyo Europe

Gesellschaft: 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

 

Regulatory Affairs Associate - EU Regulatory Procedural Management (m/f/x)

 

The Position:

Provide support for EU Regulatory Procedural Management for assigned projects including all pre- and post-authorisation activities ensuring a smooth run of regulatory procedures as well as regulatory compliance.
Act as a representative at project teams assigned, working with EU regulatory strategy leads, with affiliates, license partners and others to support procedural delivery of the projects

 

Roles and Responsibilities:

  • Support assigned regulatory submissions during development and life cycle management, in alignment with Regulatory Strategists, for European and other assigned non-EU authorities
  • Serve as a link between Regulatory Strategists, Product Support, and other disciplines in RA (e.g. RA-CMC, Labelling, Regulatory Operations, Clinical Trial Office)
  • As assigned, represent EU Regulatory Procedural Management in global regulatory and development teams and provide EU regulatory procedural guidance and operational strategy for assigned projects
  • As assigned by manager, act as the regulatory contact person for authorities pertinent to procedural matters
  • Support internal communications on regulatory status for the assigned assets
  • Ensure consistency across projects and global alignment/synergies
  • Participate in assigned non-project tasks designed to enhance the operations and processes of Regulatory Affairs
  • Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives

 

Personal skills and professional experience:

  • University degree in Pharmacy, Life Sciences, Natural Sciences or Medical Science, Master preferred; Master degree in Regulatory Affairs is a plus
  • Minimum of 1-2 years of experience in Regulatory Affairs; experience with EMA and CAPs is a plus
  • Experience of working in a global environment in interdisciplinary teams
  • Proven ability to plan, coordinate and lead activities simultaneously on multiple projects
  • Excellent personal and intercultural skills paired with the ability to work cross functionally in a multinational organisation
  • Ability to develop and maintain good relationships, challenge views, present and argue cases in a professional and respectful manner
  • Solution and detail-oriented; well organised and self-motivated
  • Strong working knowledge of Microsoft Office
  • Excellent written and oral communication skills in English, second EU 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.