Regulatory Affairs Specialist Senior
il y a 3 jours
Job Title: Regulatory Affairs Specialist Senior
Job Summary:
The Centre Européen de Recherche Cardiovasculaire (CERC) is seeking a highly skilled Regulatory Affairs Specialist Senior to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring the compliance of our clinical trials with regulatory requirements.
Key Responsibilities:
- Prepare and submit regulatory documents to Competent Authorities, Ethics Committees, and other regulatory bodies as needed.
- Provide technical and regulatory expertise for the preparation of submission documents.
- Conduct regulatory intelligence in collaboration with the Clinical Operations Manager.
- Contribute to the maintenance of the CERC Quality and Process Management System.
Requirements:
- University degree within a scientific/healthcare discipline.
- Relevant experience in clinical research and previous working experience in regulatory submissions of clinical investigations to Competent Authorities and Ethics Committees in various European countries.
- Excellent communication skills in English and ideally in another European language (Italian, Spanish, German, etc.).
- Proficient in using personal computers, including software such as Microsoft Word and Excel.
What We Offer:
- Flexible working hours.
- Free soft drinks (organic tea and coffee).
- Free organic fruits.
- Multicultural environment.
- Eco-friendly company.
- Regular in-house training sessions.
- Homeworking possible 2 days a week.
About Us:
CERC is a close-knit organization that values collaboration and innovation. We offer a dynamic and supportive work environment that encourages growth and development. As a member of our team, you will have the opportunity to work on cutting-edge projects and contribute to the creation of new innovative solutions to improve patient care.
Location: Massy, a dynamic city close to Paris, with numerous transportation options (close to Orly Airport and Massy TGV train station).
Job Type: Full-time, Permanent
Pay: From 55,000.00€ per year
Education:
- Master's (Preferred)
Experience:
- Clinical Research: 4 years (Required)
Language:
- Anglais (Required)
Work Location: Hybrid remote in Massy (91)
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