Contract Regulatory Specialist

il y a 2 semaines

Brussels, Belgique Cmed Temps plein

**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

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