Clinical Trial ; CTA Regulatory Manager

Country Clinical Trial Application (CTA) Regulatory Manager

Location:

Budapest, Hungary

Job type:
Permanent, full-time

Hybrid working

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?

Join our Global Regulatory Affairs organization as Country Clinical Trial Application Regulatory Manager (CTA-RM) and you will ensure that the regulatory dossiers related to Clinical studies (New initial CTA, Amendments, Notification, DSUR) are submitted to Regulatory or Health Authorities within set timelines for approval. The team is responsible for all the activities pertaining to Clinical Trial Applications to Regulatory Authorities in the United Kingdom, Switzerland, Australia and New-Zealand.

You will be driven to do meaningful tasks, having impact on people's health and well-being, also 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.

Main responsibilities:

• Prepare and submit CTA dossiers to Health Authorities (new initial CTAs, amendments, notifications, DSURs) for R&D and Medical Affairs, including application forms filling in line with the local regulations and in local languages when applicable, in close collaboration with the Global CTA team, and Clinical Study Unit team.
• Be accountable that regulatory dossiers related to Clinical studies are submitted and approved in due time in line with local regulation and in local languages when applicable.
• Ensure liaison with the Corporate Global regulatory Team and Clinical teams as needed for all CTA activities especially handling of questions from Health Authorities. Ensure administrative aspects are properly handled (e.g. Payments to HA).
• Be the focal point for Global Regulatory team to discuss strategies for clinical trial application.
• Be responsible for local regulatory risk assessment and management.
• Track all regulatory actions and ensure electronic archiving in appropriate databases.
• Liaise with Health Authority and develop relations with key Regulatory authorities at country level: discuss issues and find solutions in the best interests of company for regulatory dossiers related to clinical studies.
• Perform Regulatory Intelligence and regulatory requirements watch and ensure country regulatory portal is up to date.
• Analyse and communicate any changes in the CTA regulatory area and liaises with pertinent Sanofi functions to ensure implementation of new ways of working as per need.

Experience:

• Minimum of 5 years of experience in Regulatory Affairs with clinical research knowledge
• Knowledge and expertise of local regulations and thorough working knowledge of clinical trial design and development in relevant therapeutic areas
• Thorough working knowledge of all aspects of GCP and the regulatory/ethical framework pertaining to clinical trials; ability to learn and apply SOPs
• Experience working in a matrix, international, and cross-functional environment

Soft Skills:

• Good negotiation and communication skills, organizational, analytical and planning abilities, results oriented
• Problem solver with proactive mindset, able to prioritize and good with time management
• Ability to work with multi-function teams
• Ability to manage multi projects

Technical

Skills:

• Proficiency in MS Office (Word, Excel, PowerPoint), Adobe Acrobat, and collaboration tools (e.g., SharePoint, Teams)
• Experience in document management environments/systems, and/or RIM systems is highly advantageous

Education:

Minimum Bachelor's degree, or equivalent, in Regulatory Affairs, the Life Sciences, or related areas of study, and relevant experience

Language(s):
Fluent in English, with strong written and verbal communication skills

• 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 2025" 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…