Clinical Regulatory Affairs Manager

Vor 2 Tagen


Geneve, Schweiz AXEPTA Vollzeit

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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