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The Role:
We are currently looking for an enthusiastic and talented Freelance Regulatory Specialist to support the start-up of an exciting new study. This assignment can be home-based anywhere in Belgium. The anticipated resource requirement is 0.2 FTE for 6 months.
Principal Responsibilities:
- Provide support of regulatory activities, strategy, and deliverables.
- Be a specialist in local regulatory requirements, completing a range of activities in accordance with these regulatory requirements
- Collect documents required for Study Start-up’ Collect, update and maintain Information on country specific and EC regulatory requirements for clinical trials and product approvals
- Assist and provide support to the clinical study teams in the most effective and efficient manner as designated.
- Prepare and contribute to marketing authorization submissions and strategies
- Responsible for the preparation and approval of regulatory packages according to the relevant requirements for regulatory and country and Central EC/IRB submissions
- Liaise with global project team and field-based local specialists
- Prepare and approve submission packages for country regulatory, central and local Ethics Committees
- Participate in cross-functional meetings with project team and client
The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.
Essential Work Experience, Qualifications and Knowledge:
- Bachelor of Science or nursing degree
- Relevant experience in European regulatory affairs and clinical research
- Excellent knowledge of all relevant regulations Including ICH GCP
- Experience working within clinical trials from Phase I-III, preferably within Oncology
- Dutch and English required
What we offer:
- Opportunity to be part of a friendly, supportive team and work with exciting technologies
- Opportunity to work on a complex trial in challenging therapeutic area
- Competitive hourly rate
For more information on Cmed Recruitment and consideration for other opportunities, please review the recruitment statement on our careers page (https://www.cmedresearch.com/careers/).
Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by a Cmed HR or Recruitment Manager. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Cmed may directly contact for employment application.
