Oxford Global Resources
Do you have a Scientific degree? Are you communicative, detail oriented and enthusiastic to start your career in a dynamic, global company? A 1st working or internship experience in Regulatory Affairs or in Clinical Trials is a big plus but not a must. Don't hesitate and apply now!
Job Description
As RA/Clinical Site Activation Officer, you join the international Regulatory Affairs team.
You will support regulatory aspects of clinical research projects, streamline communication, maintain electronic systems and manage documents for studies in Belgium and in the Netherlands.
Responsibilities
Regulatory Affairs
- Primary responsibility for liaising with project teams to procure documents necessary for regulatory and ethics committee submissions
- Primary responsibility for the preparation of regulatory and ethics committee submission dossiers, including applications for import and export licenses, where applicable
- Responsibility for reviewing translations of essential documents subject to regulatory or ethics committee submissions, if regionally applicable (shared with project teams)
- Primary responsibility for tracking regulatory project documentation flow and progress reporting
- Primary or secondary responsibility for tracking changes/amendments to legislative acts pertaining to clinical trials in our client's countries and timely notification of all parties involved
- Supervised responsibility for maintaining a database of regulatory requirements
- Primary or secondary responsibility for registration/marketing authorization projects and renewals (where applicable)
- Primary responsibility for compilation and review of Investigational Medicinal
- Product Dossiers (IMPDs)
Communication
- Primary or secondary contact person for ethics committees and regulatory authorities
- Primary contact for project teams on all regulatory-related issues
- Secondary contact for the customer for regulatory-related issues
- Primary or secondary contact for co-contractors, subcontractors, and third party vendors (regulatory issues)
Planning & Scheduling
- Secondary responsibility for the development and update, if necessary, of project planning documents, including, but not limited to, the following: Project timelines (regulatory aspects) and Safety management plan, where applicable (in cooperation with Medical Affairs)
Quality Control
- Primary or secondary responsibility for developing and implementing corporate quality control tools and techniques pertaining to regulatory affairs
- Primary responsibility for review of investigational product release-enabling documents
Training
- Primary or secondary responsibility for training company employees in regulatory practices including, but not limited to, the following: Use of departmental software (at the discretion of senior Regulatory Affairs staff); Refresher training of company staff, pertaining to regulatory and corporate guidance documents (e.g., national regulations, regulatory-related company QSDs) at the discretion of senior Regulatory Affairs staff
Safety Management
- Primary responsibility for ensuring accurate and time-bound reporting of safety issues to authorities
- Primary responsibility for reviewing incoming safety reports for completeness
- Shared responsibility for liaising with customer safety desk and PVG units
- Primary responsibility for electronic safety reporting to/via EudraVigilance system
Corporate/Departmental Assignments
- Mentoring of CRAs, SrCRAs, and project managers in various regulatory issues (at the discretion of senior Regulatory Affairs staff)
- Participation in feasibility research (regulatory aspects)
- Assistance to business development at client presentations, bid defense meetings, and the like in various regulatory aspects (at the discretion of senior Regulatory Affairs staff)
Requirements
- University degree or equivalent combination of education, training & experience
- Life Science degree is a plus
- Prior experience in Regulatory Affairs is a plus, along with experience in, or knowledge of the Clinical Research industry
- Fully proficient in Dutch and English, and French is beneficial
- Good working knowledge of MS Office applications including Word, Outlook and PowerPoint
- The ability to plan, multitask and work in a dynamic team environment
- Excellent communication and collaboration skills
- Existing right to work in Europe is required
Benefits
- Fulltime position
- 2 days on site, and 3 days remote
- Consultancy contract for 1 year, followed by a permanent contract at the client after positive evaluation
- A balanced salary package based on your capabilities and experience, including extra legal benefits
Vacancy number: 20936
