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Global Regulatory Affairs Lead

New
  • Location: Münchendorf
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted ein Tag her

  • Sector: Pharmabranche
  • Contact: Patrick Roussos-Quandt
  • Contact Email: p.roussos@sciproglobal.de
  • Client: Takeda
  • Expiry Date: 01 July 2022
  • Job Ref: 2022_0601_1654060675

Senior Manager - Global Regulatory Affairs Lead (m/f/x) | Munich | Pharma

Are you interested in a highly visible position within a very innovative and growing company?

Are you looking for a friendly and highly motivated team to support you in your career growth?

Does a position in a global environment with broad range of tasks not only in the EU but also the US and Canada gain your interest? Are you interested in globally improving health in the world?

What are your tasks as "Global Regulatory Affairs Lead (m/f/x)"?

  • Evaluation of accelerated assessments options as well as paediatric development strategies
  • Coordination of health authority interaction as well as serving as primary liaison with the European Medicines Agency and national health authorities
  • Management, preparation and review of high-quality regulatory documents and submissions
  • Responsible person for Regulatory strategy for development projects
  • Regulatory Affairs representative in the Clinical Development Team and Project Teams as well as leader of the Regulatory Affairs Alignment Team

What requirements do you need for "Global Regulatory Affairs Lead (m/f/x)"?

  • D. or master's degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology or comparable
  • At least 5 years experience in the field of Regulatory Affairs development (INDs, Clinical, Pediatric Plans, Scientific Advise Meetings etc.) in a global environment
  • Good experience in either Biologics / Large Molecules / Vaccines
  • Good experience in setting up & implementing Global RA Strategy
  • Excellent written and verbal communication skills in English; any other language would be a plus
  • Excellent communication skills as well as ability to work as a member of a team independently
  • Very good comprehension, independent way of working, intercultural competence

What can you expect from the role?

  • An exciting position in Regulatory Affairs within a global environment
  • Great chance operating in a highly visible and key role withing the department Leader of a project team consisting of 4 people for a Phase-3 product

About the client?

Our client is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of live-saving vaccines. The company has a diverse and growing portfolio of vaccines, supported by proprietary development, public-private partnerships, and industry collaborations. The company was founded in 1994 with operations in Germany, Switzerland and USA. The company employs more than 500 people globally.

Are you interested in such company? Then you should apply now! If you would like to receive further or alternative positions, I would also be happy to receive your application!

Contact for application:

  • E-Mail: roussos@sciproglobal.de
  • Tel: +49 (0)89 / 21 093938

I am looking forward to your CV and an interesting talk with you.