(Senior) Manager Regulatory Affairs CMC (gn)

Our client is a midsize biotech company with a very interesting pipeline. With an experienced team comprised of more than 170 professionals, the company is able to span the entire value chain of biopharmaceutical drug development, from market analysis and protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.

 

Client:

  • Midsize biotech company
  • Sustainable and profitable growth

 

Benefits:

  • Friendly working atmosphere and open-minded team
  • Flat hierarchies with agile decision-making processes and plenty of room for co-determination
  • Attractive salary package and exciting development opportunities

 

Job description:

  • Planning, writing and compilation of regulatory documents for biosimilar and NBE development programs with focus on CMC for drug substance development, site transfers and life cycle activities
  • Coordination of regulatory activities for 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 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

Für nähere Informationen kontaktieren Sie bitte: / For more information please contact:

Christian Rommerskirchen
+49 0)89 212 65 333
rommerskirchen@conqure.de

Kontakt!