Ghent, Flemish Region, Belgium
- Preparation of regulatory dossiers (MAA, IMPD): project management and coordination, writing and review of CTD modules (CMC, nonclinical and module 1), meeting with regulators, response to question from regulatory authorities. - Technical regulatory affairs writer (variations, annual report), with experience on biologics (vaccines, antibodies). - Previously research scientist with extensive laboratory experience. Scientific training in top academic research institutions in Europe and USA. - Specialisation in regulatory affairs, clinical research and medical writing. Willingness to learn. - Excellent communication skills (scientific writing, public speaking, information graphics). - Design and management of projects. Organised, take-charge professional able to oversee projects from concept to conclusion. Determination to meet objectives. - Innovative thinking and a sense of initiative. - Strong background in neuroscience, stem cells, brain and spinal cord development, mouse genetics, neural circuits and systems, vaccines. - Ability to work both individually and in teams. Scientific specialties: Expertise in molecular and cellular biology, cell culture, mouse transgenesis, histology and imaging, behavioural and kinematics analysis.
- Lead GRA CMC strategies for innovative Biologics in clinical development. Nanobody molecules, Synthorin molecules and monoclonal Antibodies - Prepare INDs & CTAs dossier and support global submissions. Manage response to questions. - Lead interaction with Regulatory Agencies on CMC aspects (e.g. FDA type C meeting) - Manage a team of GRA CMC employees and contractors
- preparation and submission of a Marketing Authorization Application to EMA - preparation and submission of a Biologic License Application to FDA - regulatory assessment, change control - setting up processes for regulatory information management
External consultant (4Clinics) - write technical (module 3) parts of regulatory life cycle variations for all destinations - communicate with regulatory authorities and local operating companies: write briefing documents, progress reports, prepare meetings. - write responses to questions raised by regulatory authorities on CMC matters - provide support to transversal regulatory CMC activities
Consultant in technical regulatory affairs at GSK Vaccines www.4clinics.com
- provided support for the writing of medical documents required during clinical programs (clinical study protocols, clinical study reports, narratives, informed consent forms, diary cards,...). - writing according to 4Clinics' SOPs and ICH guidelines. - performed quality control of documents, implementation of reviewers comments. - conducted literature searches. Mentor: Dr. Anne Hepburn
Research projects management. My postdoctoral studies were centered on the development, organization and functioning of neural circuits and how they mediate behavior. I also developped and implemented molecular tools for functional and imaging studies. The long term goals are to define the elements and processes essential to normal function of complex neuronal networks and to use this knowledge to reveal the alterations that characterize neurological disorders. Postdoctoral research focus: Identification and analysis of spinal interneurons required for locomotor function (Prof. Martyn Goulding's laboratory). - used advanced mouse genetics to study the anatomy, connectivity and function of molecularly-defined neurons. - designed and implemented a novel transgenic strategy for conditional and inducible ablation of genetically-defined classes of spinal interneurons. - set up the behavioural and kinematics analyses of mouse locomotion in the laboratory (selected and purchased equipment/software, designed apparatus for locomotor tests, provided training and support to lab users and collaborators).