Regulatory Lead and International Regulatory Manager – France – Homebased

Regulatory Lead and International Regulatory Manager – France – Homebased

One of our partners, a small/mid-sized CRO, are looking to further strengthen their regulatory capabilities in France, and are seeking an experienced regulatory manager who can independently manage CTAs and submissions packages across France and Belgium, as well as act a regulatory lead on regional and cross-regional programmes.

This is a unique, hybrid role, one which requires hands-on management of French/Belgian submissions packages, but also one that requires both scientific and strategic input on the greater clinical development programme, as well as negotiating and influencing the ASNM to drive programmes forward for more successful and prosperous relations.

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’