Upsilon Global

Regulatory Affairs and Submissions Manager – Homebased - France

2 days left

France (FR)
up to €70,000
03 Feb 2021
05 Mar 2021
Regulatory Affairs
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Regulatory Affairs and Submissions Manager – Homebased - France

Upsilon Global are hiring for an experienced regulatory expert in France to review, coordinate and complete EC/RA submissions across France and Belgium. As well as being the responsible person for France, you will also act as lead regulatory expert to oversee international submissions packages, working closely with the Head of Regulatory Affairs to coordinate the activities of local regulatory associates across Europe, as well as presenting at sponsor meetings, so you must be a positive leader and commercially confident.

This is a fantastic opportunity for anyone who’s looking for greater responsibility, leading both local and international submissions packages for a growing CRO. You must be autonomous and self-managed, as well as a confident leader and someone who can work closely with the global head of regulatory affairs as the company expands operations.

Our partner, a small/mid-sized CRO with 150 headcount globally, are one of Europe’s most exciting CROs, gaining international recognition for their performance, quality standards and training & development programmes.

Fantastic salary and benefits available, home-working, flexible hours and great management and support structure. 

Main responsibilities:

  • Co-ordinate clinical trial applications in various countries in collaboration with cross-functional teams.
  • Perform local clinical trial applications across France and Belgium to ensure successful outcome.
  • Budget and contracts’ negotiation: draft or review site clinical trial agreements to ensure timely clinical trial start and compliance to the applicable local legislation.
  • Provide support for activities with outside vendors and business partners, as required (such as service agreements and work orders review).
  • Ensure that regulatory documentation and contracts are compliant to legal, regulatory regulations and company SOPs.
  • Facilitate proper filing of relevant documentation.
  • Ensure proper tracking of start-up activities in Company’s project management tools.
  • Track changes/amendments to legislative acts pertaining to clinical trials in participating countries and timely notification of all parties involved; liaise with other local teams to collate the relevant regulatory framework.
  • Assist in relevant SOPs and guidelines’ writing, maintenance.

Job Requirements Qualifications:

  • 2 - 4 years’ experience in managing regulatory aspects of clinical trials; good knowledge of relevant regulatory environment.
  • University degree in Life Sciences is preferred.
  • Excellent command of English, both oral and written.
  • Excellent communication, planning and organizational skills.
  • Demonstrated ability to work effectively in a fast-paced environment.
  • Proficiency in standard MS Office applications.

For further information on this opportunity and to learn of similar positions, please contact Upsilon Global on +44. (0). 20. 3. 87. 5.  99. 66. or email ‘applications (at) upsilonglobal . com’

Apply for Regulatory Affairs and Submissions Manager – Homebased - France

Already uploaded your CV? Sign in to apply instantly


Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB

4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.

When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs