Clinical Trials Regulatory Lead
vor 1 Tag
The Role
Clinical Trial Regulatory Lead
At Roche, we are committed to developing life-improving therapies worldwide. As a Clinical Trial Regulatory Lead, you will play a crucial role in shaping our regulatory strategy and submissions globally (excluding US, China, and Japan) for molecules and medical devices.
You will work closely with early research and development functions, affiliates, product development, and technical regulatory teams to develop and realize clinical trial submission strategies, build regulatory submissions, and deliver fit-for-purpose solutions to achieve our organizational goals and objectives.
In this dynamic and multifaceted environment, you will require strong global clinical trial regulatory knowledge, an innovative mindset, and a willingness to push boundaries to get patients faster access to treatments.
Your Key Responsibilities
- 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.
- Engage in dialogue with health authorities to ensure efficient approvals of submissions and shape the external regulatory environment.
- Lead clinical study submissions to Health Authorities globally (excluding US, China, and Japan) including strategy, compilation, and lifecycle management.
- Lead/participate in cross-organizational/enterprise level projects and initiatives.
- Partner with global policy to shape the external regulatory environment.
- Invest in your own learning and development, in addition to coaching and mentoring the development of other team members.
- Identify and pursue opportunities to optimize the clinical study processes.
Your Requirements
- You are keen to develop regulatory insights through your experience, regulatory, and scientific knowledge to determine solutions and solve problems. You demonstrate the ability to assess priorities and pivot as required and set strategies to align with dynamic business and environment needs. You seek improvements (including digital solutions) in work processes while using judgment to balance creativity with compliance and the requirement to meet timelines.
- You influence directly or indirectly the internal and external health authorities, CROs, IVD manufacturers stakeholders on more than one level who may have different interests or goals to reach consensus and achieve team objectives. You are able to communicate effectively in a multicultural, multi-functional environment. You are able to lead teams through submission activities to meet critical timelines and goals.
- You work effectively to share responsibility as a team member in a customer-focused environment. You share information, knowledge, and guidance, mentoring, and onboarding new team members. You approach work with a positive and curious attitude.
- Knowledge and proven expertise in EU clinical trial regulation/IVDR and other relevant clinical trial and device regulatory legislation and guidelines in Europe and of key international countries (as well as other countries) in order to support global clinical studies. 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.
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