Regulatory Affairs Officer/Senior Officer
A leading, full-service global Contract Research Organisation (CRO) is advertising a vacancy for a Regulatory Affairs Officer/Senior Officer. The company, which specialises in predictable patient enrolment across multiple therapeutic areas, is seeking for the Officer to join their office in Paris.
- Prepare clinical trial submission dossiers for Regulatory and Ethics Authorities, including Import and Export license applications.
- Communicate with regulatory authorities, ethics committees, project teams, and vendors on regulatory-related matters.
- Review translations of essential documents subject to clinical trial submission.
- Track the regulatory project documentation flow.
- Review documents to greenlight IP release to sites.
- Manage safety reporting to authorities.
- Deliver regulatory training to project teams.
- Assist with feasibility research and business development requests.
Skills and Requirements:
- College/University degree or an equivalent combination of education, training, and experience.
- Prior regulatory experience with clinical trial submissions in France.
- Full working proficiency in English and French.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at +44 203 869 2329 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.