Job Description: Clinical Trial Regulatory Lead (CTRL)
Location: Budapest, Hungary
Position Type: Full-time
Work Flexibility: 2 office days per week, fully remote working conditions within Hungary available.
Benefits: Competitive salary, cafeteria package, annual bonus, private medical services, employee assistance program, sport pass, coaching/mentoring, team-building activities, and more.
About Roche
Roche is a global leader in research-focused healthcare, with over 100,000 employees across 100 countries. With a commitment to innovation, curiosity, and diversity, Roche is dedicated to pushing back the frontiers of healthcare to meet the needs of patients worldwide. Roche's success is built on diverse and collaborative teams, and our operations in Hungary are key to delivering end-to-end business solutions across finance, procurement, IT, communications, and human resources.
Position Overview
As a Clinical Trial Regulatory Lead (CTRL), you will play a pivotal role in supporting the global regulatory function by driving the development and delivery of regulatory strategies for clinical trials. You will engage with a variety of stakeholders across research and development (REDs), product development (PD), affiliates, and technical regulatory teams to ensure the successful submission and execution of clinical trials globally.
The CTRL will also contribute to the development of future organizational capabilities, providing leadership and guidance on regulatory issues while optimizing project delivery and process improvements.
Key Responsibilities
Regulatory Expertise and Guidance
Serve as the primary point of contact for regulatory clinical trial expertise, providing insights and critical guidance across projects.
Collaborate with various teams to ensure compliance with global regulatory requirements and streamline clinical trial processes.
Strategic Leadership and Risk Management
Challenge existing strategies and connect the dots across different projects to propel the organization forward.
Improve efficiencies by applying cross-study learnings and promoting best practices across trials.
Regulatory Submissions
Lead the development and submission of global clinical trial documents to health authorities.
Engage in regulatory dialogues, shape the external regulatory landscape, and work closely with external partners (e.g., CROs, IVD manufacturers) to ensure successful outcomes.
Adaptation to Regulatory Changes
Stay updated on external regulatory changes and adapt internal processes accordingly.
Ensure that internal regulatory practices remain aligned with global standards.
Team and Talent Development
Provide coaching, mentoring, and continuous learning opportunities to team members.
Contribute to the development of organizational capabilities through feedback and shared expertise.
Who You Are
Experience:
1-3 years of experience in regulatory affairs or clinical trials, with a strong interest in regulatory insights.
Bachelor’s degree required.
Skills and Abilities:
Ability to balance creativity and compliance, applying judgment to meet timelines and deliver high-quality results.
Strong communication skills and the ability to work effectively in a multicultural, multi-functional environment.
Demonstrated leadership potential, able to lead teams through complex regulatory activities.
Collaboration and Influence:
Proven ability to influence internal and external stakeholders, including health authorities and CROs, to align on common goals.
A team player with the ability to share knowledge and mentor colleagues.
Curiosity and Innovation:
A positive, curious demeanor with a drive for continuous improvement and finding solutions, including through digital tools.
What Roche Offers You
Development Opportunities:
Roche provides rich learning resources, including free language courses, international assignments, and internal position changes. You will have the opportunity to shape your career with continuous learning and growth.
Work-Life Balance:
Enjoy flexibility with 2 office days per week and fully remote work options within Hungary. Roche promotes a healthy work-life balance and offers an excellent benefits package.
Inclusive and Collaborative Environment:
Roche fosters an inclusive culture where diverse perspectives are celebrated, and everyone is encouraged to contribute. You’ll have the opportunity to work with a global, diverse team and contribute to the advancement of healthcare solutions.
Roche is an Equal Opportunity Employer.
We are committed to creating a diverse and inclusive workplace where all employees feel valued and have the opportunity to reach their full potential.
Apply now to be part of Roche's mission to transform healthcare through innovative regulatory solutions in clinical trials.
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Bangor | Brewer |Maryland :
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Dunboyne |Republic of Ireland :
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China | Quarry Bay |Hubei :
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Hangzhou |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
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Montreal |Chile :
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Croatia |Zagreb :
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Prague |Republic of Egypt :
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Turku |France :
Paris | Lyon |Attica :
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Yavne | Netanya | Be'Er Sheva | Kfar Saba | Tel Aviv |Italy :
Italy |Lombardy :
Rho |Japan :
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Riyadh | Khulais | Jeddah | Rabigh | Najran | King Abdullah Economic City |Nišava District :
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Taipei |Williamson :
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