Regulatory Coordinator support for Clinical Trial Application (CTA)

Job description

Our position

·  Job title: Regulatory coordinator support for Clinical Trial Application (CTA)
·   Location: Budapest, Hungary - remote negotiable
·  Job type: Permanent full-time

About the job

Our Team:

We are currently on a journey where we are transforming how we support our Global Regulatory Affairs (GRA) teams  and are looking for team members who can join us on this exciting journey.  

As a member of the Regulatory team in charge of Clinical Trial Applications (CTA),  the CTA support Coordinator drives the day-to-day execution of the preparation of CTA (initial CTA, maintenance and closure activities).   

The CTA coordinator support will be a key member of a highly productive team, a collaborative team player, and driven by problem solving and ways of working improvement spirit, in order to achieve final Sanofi’s goal to conduct Clinical studies to bring new innovative medicines to patients.

Main responsibilities:

Primary areas of responsibility include:

·  Follow up/monitoring of CTA operational planning activities.
·  Manage activities related to CTA documentation in close collaboration with the Clinical trial team, and the Regulatory team (coordinate, follow, check availability of component and completeness  of CTA dossier  and ensure availability of documents for Initial Clinical Trial Applications (CTA) preparation, CTA amendments, etc.).
·  Manage activities specifically related to the Clinical trials under the European Regulation and its operational processes in the Clinical Trial Information System (CTIS).
·  Prepare appropriate CTA documents in the Sanofi repository systems.
·  Activities related to Development Safety Update Report (DSUR) delivery.
·  Manage activities related to tools /Sanofi Regulatory document and registration tracking tools (Vault RIM).
·  Contribute to data QC, and appropriate data remediation.
·  Monitor Key Performance Indicators by running reports, collating data and report as per oversight and governance process.
·  Contribute to the Regulatory Intelligence process.

About you

Experience :

·  Knowledge and operational expertise in clinical trials regulation or regulatory affairs is preferred.
·  Awareness or experience with Artificial Intelligence is desirable, however not essential.

Soft Skills:

·  Proactive and ability to embrace new activities.
·  Willingness to learn and to work with multifunctional and multicultural teams.
·  Ability to communicate effectively and efficiently with a dedicated and persuasive “can-do” attitude and entrepreneurial spirit.
·  Collaborative team player with orientation towards building and maintaining effective relationships, strong culture awareness.
·  Ability to operate with agility in a dynamic global environment and propose solutions and proactivity solve problems.
·  Ability to maintain discretion and confidentiality about sensitive data.
·  Strive to meet short deadlines and shifting priorities with demonstrated continuous improvement mindset.

Technical skills :

·  Working knowledge in Microsoft Office and Windows (Outlook, Word, Excel, PowerPoint), web skills a plus.
·  Understanding of the relationship between systems and electronic databases.  

Education :

·  Bachelor’s degree or equivalent in regulatory affairs, or The Sciences, Pharmacy or related areas in Clinical study, and relevant experience (Science Degree or Life Sciences Degree).

Languages :

·  Strong command of the English language, ability to communicate in English (verbally and written) effectively and efficiently across varying functions and levels of management.​

Pursue progress. Discover extraordinary.

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability, gender identity or Veteran status.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !

Discover our Code of Conduct , that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.

#Sanofi

#WeNeverSettle       

#SanofiCareers

#PursueProgress

#DiscoverExtraordinary

#joinsanofi

#careerswithpurpose

#GRA

#clinicalsciencesoperations

#SanofiBudapestHub

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.