Job offer

20201951

Consultant Regulatory Affairs CMC (m,w,d)

Company

For our client is a global pharmaceutical and innovative company located in Bavaria.

Main tasks

  • Preparation of M2.3 (Quality Overall Summary) and M3 CTD documents for late stage development biologics, supporting EU MAAs and IMPDs filings
  • Provides regulatory counsel in document authoring, review and document management system
  • Review CMC documents, develop regulatory strategies, and provide risk assessments
  • Interpret, develop strategy and lead response preparation on Health Authorities information requests
  • Collaborate closely on project-related tpoics with global RACMC and technical experts, across all regions
  • Keep current with review and interpret regulatory and scientific regulations, directives, guidelines and initiatives, communicate important changes and trends with the relevant stakeholders

Requirements profile

  • Master degree in Life Science or Pharmacy, PhD preferred; Master Degree in Regulatory Affairs is a plus
  • Minimum of 8 years of project experience in global regulatory affairs CMC with emphasis on late stage CMC drug development of biologics (e.g. mAb, ADCs, etc.) and marketing authorization applications in Europe
  • 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 organization
  • Experience of working in global environment in interdisciplinary teams
  • Solution and detail-oriented; well organized and self-motivated
  • Excellent written and oral communication skills in English, German as a second language necessary
  • Strong working knowledge of Microsoft Office

Contractual conditions

  • Volume 4-5 days/week
  • Freelance project
- Remote possibilities given
  • Travelling not planned
  • Start: 01.06.21 End: 31.05.22; Extension possibilities given

Contact

Consigen GmbH
Doris Ehrmann
Mail: doris.ehrmann@consigen.de
Fon: +49 281 3008424
Mobil +49 173 700 49 44
www.consigen.de