• Location: Budapest, Hungary
• Job type: Permanent, full-time
• Hybrid working
  

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Sanofi Global Regulatory Affairs is looking for a Regulatory Clinical Trial Application coordinator support (CTA-CS) to join the team to execute CTA related activities in support of the Clinical Trial Applications processes (end to end process) of company Clinical Trials (CT).

In this role you will be driven to do meaningful tasks, having impact on people’s health and well-being.  In the CTA-CS activities you 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:

• Follow up/monitoring of CTA operational planning activities
• Manage activities related to documentation:
  • In close collaboration with the Clinical trial team, the Regulatory team (follow, check, and ensure availability of documents for Initial Clinical Trial Applications (CTA) preparation, CTA amendments, etc.)
  • Check CTA package completeness according to planning including version control, review and approval
  •  Coordinating translation requests if needed, and content owner review of materials for feedback and revision
  • Prepare necessary administrative Clinical trial application documents
• Manage activities related to the Clinical trials under the EU Regulation and its operational processes in the Clinical Trial Information System (CTIS)
• Prepare CTA documents in the Sanofi repository systems activities related to Development Safety Update Report (DSUR), ensure distribution preparation and tracking submissions for all entities
• Manage activities related to tools /Sanofi Regulatory document and registration tracking tools (Vault Regulatory Information Management (RIM)):
  • Creation and update of CTA related data objects, track review workflow
  • Contribute to data quality control and data remediation in Vault RIM
  • Follow-up of submission and approval of CTA package with affiliates / partners
  • 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 is preferred

Knowledge, soft skills and competencies:

• Excellent verbal, written, organizational and interpersonal skills with a sharp attention to detail and the ability to handle multiple tasks simultaneously
• Collaborative team player with orientation towards building and maintaining effective relationships, with strong culture awareness
• Ability to work under pressure, adaptability to change and embrace new activities, solve problems and willingness to learn to drive to meet short deadlines and shift priorities
• Ability to communicate effectively, verbally and written, across varying functions and levels of management
• Demonstrated continuous improvement mindset, with entrepreneurial spirit, dedicated and persuasive “can-do” attitude

Technical skills:

• Skilled in MS Office Suite and web applications
• Good understanding of the relationship between systems and electronic databases 
• Experience with Veeva tools and or Veeva Vault/RIM is a plus

Education:

• Minimum Bachelor’s degree or equivalent in Regulatory Affairs or Life Sciences

Languages:

• Excellent written and verbal communication skills in English

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
• Work from an "Office of the Year 2023" award winner with flexible home office policy
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave
• An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

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 #SanofiCareers #joinSanofi

#jobopportunities #careeropportunities #sscjob

#Sanofi_Budapest_Hub #Budapest

#R&D #regulatoryaffairs #clinicaltrial #CT #CTA #CTC #clinicaltrialapplication #clinicaltrialcoordination #CTIS #RIM

#LI-EUR #LI-hybrid

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Pursue Progress. Discovery Extraordinary.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.