Clinical Trial Regulatory Lead
vor 2 Monaten
As a Clinical Trial Regulatory Lead at Roche, you will play a critical role in shaping the company's regulatory strategy and submissions 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 execute global clinical trial regulatory strategies and submissions for molecules and medical devices.
- Collaborate with cross-functional teams, including early research and development, affiliates, product development, and technical regulatory, to ensure seamless execution of clinical trial submissions.
- Provide expert advice and regulatory insights to the organization on external and internal requirements for clinical study procedures and monitor the regulatory landscape for changes.
- Lead the regulatory procedure for Clinical Studies submissions, engaging in dialogue with health authorities to ensure efficient approvals and shape the external regulatory environment.
- Lead clinical study submissions to Health Authorities globally, including strategy, compilation, and lifecycle management.
- Participate in cross-organizational/enterprise level projects and initiatives, partnering with global policy to shape the external regulatory environment.
- Invest in your own learning and development, as well as coaching and mentoring the development of other team members.
- Identify and pursue opportunities to optimize clinical study processes.
- Proven expertise in EU clinical trial regulation/IVDR and other relevant clinical trial and device regulatory legislation and guidelines in Europe and key International countries.
- Good knowledge of GCP principles applied globally.
- Working knowledge of Clinical Trial Information System (CTIS) and the Veeva vault systems (specifically the regulatory vault) is an advantage.
- Strong global clinical trial regulatory knowledge, innovative mindset, and willingness to push boundaries to get patients faster access to treatments.
- Excellent communication and leadership skills, with the ability to influence stakeholders and lead teams through submission activities to meet critical timelines and goals.
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