Regulatory Affairs Specialist Senior

il y a 3 jours


Mâcon, Bourgogne-Franche-Comté, France CENTRE EUROPEEN DE RECHERCHE CARDIOVASCULAIRE Temps plein

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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