Regulatory Affairs and CMC Manager Job Summary:
As part of our growth strategy and product portfolio, we are offering a new challenge as Manager RAC (Regulatory Affairs & CMC).
You will be a member of the local regulatory affairs and CMC team dedicated to Drug Substance and ADCs/Bioconjugates Business Unit and will support customer activities focusing on Chemistry Manufacturing and Controls (CMC) for Biologics and Chemistry projects.
In this very dynamic and hands-on role, you will work collaboratively with other departments to coordinate the regulatory activities from clinical development up to market launch and life cycle management.
Key Responsibilities:
* Authoring/Reviewing and Maintaining Registration Documents
* Assisting with Submission of Post-Approval Change Documentation
* CMC Regulatory Support during Entire Process and Product Development
* Leading and/or Conducting Project Specific CMC Regulatory Gap Analysis
* Collaboration with Health Authorities/Customer Projects
* Supporting Internal Non-Customer Oriented Regulatory Projects
Requirements:
* Master or Engineering Degree in Biochemistry, Chemistry, Pharmacy, or Equivalent Scientific Discipline
* Good Understanding of Regulatory Affairs for Drug Substance with Focus on CMC Development for Biologics and/or Chemical Products
* Good Knowledge of cGMP Regulations
* At Least 5 Years Experience in Pharmaceutical Industry
* Previous Experience in CDMO or Customer Projects Advantageous
* Team-Oriented, Pro-Active Problem-Solving Mentality, Service-Oriented Mindset with Flexibility to Handle Multiple Tasks
* Good Coordination and Communication Skills - Fluency in English Required; Basic Knowledge of German Recommended
* Good Sense of Responsibility and Reliability
* Knowledge of eCTD Submission Software (Docubridge) Advantageous