Clinical Trial Regulatory Expert
Vor 7 Tagen
About the Role
As a Clinical Trial Regulatory Lead at Roche, you will play a critical role in shaping the company's regulatory strategy for clinical trials globally. This is an exciting opportunity to work with a dynamic team and contribute to the development of life-changing therapies.
Key Responsibilities
- Develop and implement regulatory strategies for clinical trials, ensuring compliance with global regulations and guidelines.
- Lead the preparation and submission of clinical trial applications to health authorities worldwide.
- Collaborate with cross-functional teams, including research and development, to ensure seamless execution of clinical trials.
- Provide expert advice on regulatory requirements and guidelines to internal stakeholders.
- Stay up-to-date with changes in regulatory landscapes and adapt strategies accordingly.
- Lead and participate in projects and initiatives to optimize clinical trial processes and improve efficiency.
- Partner with global policy teams to shape the external regulatory environment.
- Invest in personal and team development, including coaching and mentoring.
Requirements
- Proven expertise in EU clinical trial regulation and other relevant clinical trial and device regulatory legislation and guidelines.
- Strong knowledge of GCP principles and clinical trial information systems.
- Excellent communication and leadership skills, with the ability to influence stakeholders at all levels.
- Ability to work in a multicultural, multi-functional environment and adapt to changing priorities.
- Positive and curious attitude, with a willingness to learn and grow.
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