Regulatory Affairs Senior Specialist

Location Mont-Saint-Guibert, Belgium
Discipline: Biotechnology, Pharmaceutical
Job type: Permanent
Contact name: Cherish Becker

Contact email: c.becker@panda-int.com
Job ref: 10724
Published: 18 days ago

YOUR RESPONSIBILITIES

  • Regulatory Lead for assigned Oncology CAR T cell pipeline projects;
  • Develop and implement innovative global regulatory strategies for assigned projects;
  • Provide guidance to team on Regulatory CMC, Nonclinical and Clinical topics;
  • Develop detailed regulatory project plans and timelines for assigned projects; identify critical path activities, risks, gaps and mitigations;
  • Manage regulatory submissions and rapid responses to Health Authority questions according to required timelines; coordination with internal and external collaborators;
  • Liaise with individual contributors and Subject Matter Experts to develop key messages and complete regulatory submission documents;
  • Write, prepare and review well-organized, scientifically sound regulatory documents;
  • Format submission-ready documents to meet eCTD publishing requirements;
  • Track submissions, archive correspondence, and maintain regulatory documentation;
  • Maintain knowledge of current regulatory landscape and competitive intelligence;
  • Review and interpret regulatory, clinical, scientific and other technical documents;
  • Contribute to new internal documentation, SOPs and checklists as assigned;
  • Additional support with department and company objectives as assigned;

YOUR DETAILS:

  • Masters in Pharmaceutical/Life Sciences with 5 years in a biopharma regulatory role or PhD in Pharmaceutical/Life Sciences with 3 years in a biopharma regulatory role;
  • Expertise in Immuno-Oncology and Advanced Therapy Medicinal Products;
  • Experience in eCTD-compliant regulatory submissions;
  • Experience working within a Quality Management System (GxPs);
  • Knowledge of European, US and International laws, regulations and guidelines for biologics and human cells and tissues.
  • Fluent English (written and spoken), additional languages are an asset.

INTERESTED?

For more information please contact me at:  +31 (0)20 20 44 502 or c.becker@panda-int.com.