Clinical Regulatory Affairs Manager
Vor 6 Tagen
My client, a global and growing biopharmaceutical company is looking for
their new position as Regulatory Affairs Clinical Manager to join their team
located in Geneva canton.
Tasks
**YOUR RESPONSIBILITIES**:
- Be the main person in the regulatory affairs team
regarding the clinical sections for regulatory submissions
- Ensure regulatory tools to support the set-up,
conduct, and completion of clinical trials
- Work closely with the clinical study teams and
represent Regulatory Affairs team as needed
- Ensure that trial registrations and results data are
posted online to the required clinical trial portals and databases
- Work with external CROs if needed for some regulatory
affairs clinical part.
- Support clinical study team members for the regulatory
sections of clinical trial master files, and for the maintenance of any other
related clinical documentation within regulatory.
- Monitor national and international registration
requirements through reviews of websites, publications, seminars, and similar
sources, and communicate requirements
**Requirements**:
**YOUR PROFILE**:
- Master or PhD in the LifeScience with minimum 5 years
experience in Regulatory Affairs Clinical.
- Strong experience with the global regulatory
environment, GCP regulations and CTA/IND processes
- Good understanding of the set-up and management of clinical
trials
- Knowledge of the new EU Clinical Trial Regulation and ETMF management is
a plus
- Fluent in English
-
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