Regulatory Affairs Clinical Manager - Geneva

Job content

In view of our continued global growth, we are recruiting aRegulatory Affairs Clinical Manager at our headquarters in Geneva. Reporting to the Regional Regulatory Affairs Head EU/CH/US, your mission is to provide regulatory support to the clinical operations and development activities.

Your Main Responsibilities Are As Follows

• Support the Regulatory Affairs team with the coordination and preparation of the clinical sections for regulatory submissions
• Develop and maintain regulatory tools to support the set-up, conduct, and completion of clinical trials
• Act as primary representative for Regulatory Affairs on assigned clinical study teams and represent Regulatory Affairs on cross-functional initiatives related to clinical processes
• Support clinical study team members in the auditing and records management for the regulatory sections of clinical trial master files, and for the maintenance of any other related clinical documentation within regulatory, including any regulatory clinical database areas
• Ensure trial registrations and results data are posted online to the required clinical trial portals and databases (i.e. EudraCT, clinicaltrialregister.eu, clinicaltrials.gov, etc.) either directly or in coordination with external CROs
• Support development of OM cross-functional R&D clinical procedures, and for organizational structure and systems related to clinical research
• Monitor national and international registration requirements through reviews of websites, publications, seminars, and similar sources, and communicate requirements within the RA staff
  
  

To carry out this mission, we are looking for a person with the following profile:

• University Degree in Life Sciences or equivalent
• At least 5 years of experience in Regulatory Affairs within the pharmaceutical industry, preferably linked to the set-up and management of clinical trials
• Familiarity with the global regulatory environment, GCP regulations and CTA/IND processes
• Ideally, knowledge of the new EU Clinical Trial Regulation and ETMF management
• Fluent in English (both written and spoken), French is an asset
  
  

You describe yourself as a dynamic and autonomous person. Thanks to your communication and interpersonal skills, you know how to establish collaborative links with multi-cultural teams. Endowed with an entrepreneurial spirit and leadership skills, you are able to manage different cross functional stakeholders and feel comfortable in a position where you need to make decisions and take initiatives to move things forward. Finally, your pragmatic mindset and your flexibility allows you to collaborate efficiently across the organization in an agile way.

Are you interested in this opportunity? Apply as soon as possible and join OM Pharma!

About Us

OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.

It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections.

The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.

For more information, visit the website: ompharma.com .