Date: as soon as possible – full-time

Your responsibilities:

  • Planning, writing and compilation of regulatory documents for Formycon`s biosimilar development programs with focus on CMC documentation for analytical development programs (e.g. characterization studies, analytical similarity/comparability studies, method qualification/validation studies) including lifecycle activities
  • Coordination of regulatory activities for Formycon`s Biosimilar development programs with involved stakeholders (e.g. internal functional departments, external CMOs/CROs, license Partners)
  • Development and implementation of CMC regulatory strategies during product development and throughout lifecycle. Ensure that relevant regulatory requirements and guidelines are taken into account and implemented in the biosimilar development programs
  • Participation in technical project teams and point of contact for external partners and CMOs/CROs for regulatory topics
  • Review and approval of documents/plans/reports from CMOs/CROs and internal functional departments
  • Regulatory compliance check of documents and evaluation of change controls

Your qualifications:

  • Scientific background with bachelor or master degree preferably in biology, biotechnology, pharmaceutical sciences, chemistry or equivalent
  • Ideally two or more years of experience in either CMC RA area with focus on analytics or analytical laboratory background with proven track in compilation and/or review of analytical reports
  • Practical experience in compilation of CMC documentation for IMPD/IND, BLA/MAA for biotech products required
  • Experience with biosimilars and knowledge of corresponding EMA/FDA guideline requirements would be of advantage
  • Ability to coordinate, prioritize and manage a variety of tasks and issues
  • Team player, flexible and dedicated personality
  • Fluent in English (German language a plus)

Bring us your skills and energy, and shape your own career in a stimulating and open work environment. We are looking for highly motivated individuals who are ready to take on new challenges with enthusiasm and personal commitment. Working at Formycon means being part of a smart, innovative team with minimal hierarchy and opportunity to share your own ideas.

Have we sparked your interest? Then we look forward to receiving your application for employment through our online application portal. Please be sure to include all supporting documents, along with your earliest possible starting date and your salary expectations. We look forward to learning about you and the qualifications which you would bring to this position.