Frank Vandendriessche

Pharmacist with PhD in Pharmaceutical Sciences and additional training in evidence based medicine, health economics and health technology assessment.

20 years experience in 3 Top-10 pharmaceutical companies (Pfizer AH, GSK Biologicals, Merck/MSD) and 10 years in Strategic and Scientific RA Consultancy services.

Experienced in regulatory affairs supporting drug development and life cycle management.

Acted at middle and senior management level across functions, regions and companies.

Managed, coached and developed regulatory affairs professionals & other subject matter experts in direct and matrix reporting:
- Led regulatory scientists, managers, directors and contributed to (re)organisation of RA Departments.
- Directed complex regulatory projects, ensuring high quality and timely output in compliance with external and internal rules, policies and SOP’s and budget constraints.
- Operated in multidisciplinary teams including R&D, clinical R&D, manufacturing, QC/QA, regulatory affairs, pharmacovigilance, medical and scientific affairs, marketing and market access functions.
- Managed internal and external stakeholders and contributed to business development.

Seasoned in all aspects of pharmaceutical regulatory affairs (quality, non-clinical, clinical, EU procedural and policy), particularly in quality of biologicals/biosimilars, (immuno)oncology, and vaccines: BioOncoVac.
- Developed realistic, robust regulatory strategies supporting business goals.
- Extensive hands-on experience in writing and reviewing regulatory documents.
- Strong track-record of successful regulatory agency interactions & approvals of regulatory submissions, including new product licenses.
- Represented the company in regulatory groups of trade associations.