The Life Science Career Network

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes. 

Our client develops innovative therapeutic antibodies in immuno-oncology fighting cancer cells by reactivating the body's own defense mechanisms. 

For the next possible date we are looking for a Senior Manager regulatory Affairs to step in a permanent position.

Senior Manager Regulatory Affairs (m/w/d)

Responsibilities

  • Implement regulatory strategy and manage operational activities for assigned products/programs
  • Provide input into global regulatory strategy and contribute to Regulatory Strategy Plan (RSP) or equivalent, including identification of gaps or risks, for assigned products/programs
  • Drive coordination, planning, and submission of regulatory documentation (e.g. PIND, INDs, Scientific Advice, ODDs, PIPs, MAAs etc.) of assigned products worldwide
  • Facilitate timely submission and approval of dossiers with HAs under the guidance of the Sr. Director RA
  • On time submission of annual reports and updates for assigned products
  • Ensure regulatory compliance for assigned project(s) and keep records of all major HA interactions
  • Ensure quality and compliance with global regulatory requirements (in applicable regions) and adherence to regulatory internal policies and processes
  • Represent RA on cross-functional teams or sub-teams as required
  • Collaborate proactively with all internal and external stakeholders (CRO’s, consultants)
  • Prepare and compile the dossier in submission-ready format according to the regulatory requirements of applicable regions by involving external vendors when necessary
  • Keep and further develop competence in regulatory affairs and provide training to other staff when needed

Qualifications & Experience:

  • University Degree in Natural Science or equivalent education with at least 5 years working experience in Regulatory Affairs in more than one region across the globe
  • Post-Doctoral Degree and regulatory competence certifications are a plus
  • Very good understanding of the regulatory requirements and guidelines for filings worldwide and critical evaluation of emerging requirements and guidelines for new drugs
  • Demonstrating ability to work independently on multiple projects in parallel
  • Strong communication and presentation skills
  • Excellent team player
  • Have a solution-oriented mindset
  • Fluent in English (written and oral)

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.