Regulatory Lead for Clinical Trials

vor 1 Monat

Basel, Basel-Stadt, Schweiz Roche Vollzeit
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Job Summary

We are seeking a highly skilled Clinical Trial Regulatory Lead to join our team at Roche. As a key member of our Pharma Development Regulatory organization, you will be responsible for leading the clinical trial regulatory strategy and submissions globally (excluding the US, China, and Japan) for molecules and medical devices.

About the Role

As a Clinical Trial Regulatory Lead, you will engage across early research and development functions, affiliates, product development, and technical regulatory to develop and realize clinical trial submission strategies. Your expertise will be essential in building regulatory submissions and delivering fit-for-purpose solutions to achieve organizational goals and objectives.

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 the 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, as well as coaching and mentoring the development of other team members.

Requirements

  • You will have keen regulatory insights and scientific knowledge to determine solutions and solve problems. You will demonstrate the ability to assess priorities and pivot as required, set strategies to align with dynamic business and environment needs, and seek improvements in work processes while using judgment to balance creativity with compliance and meeting timelines.
  • You will influence stakeholders, including health authorities, CROs, and IVD manufacturers, who may have different interests or goals to reach consensus and achieve team objectives. You will be able to communicate effectively in a multicultural, multi-functional environment and lead teams through submission activities to meet critical timelines and goals.
  • You will work effectively to share responsibility as a team member in a customer-focused environment, share information, knowledge, and guidance, mentor, and onboard new team members. You will 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 key international countries is essential. Good knowledge of GCP principles applied globally is also required. Working knowledge of Clinical Trial Information System (CTIS) and the Veeva vault systems is an advantage.

About Roche

Roche is the steward of the safety and efficacy of medicines, collaborating with regulators of every country in which we do business to help them understand our products' clinical value. We work across industry and regulators to continually evolve regulatory policy.

What We Offer

As a Clinical Trial Regulatory Lead at Roche, you will have the opportunity to work in a dynamic and multifaceted environment, requiring strong global clinical trial regulatory knowledge, an innovative and experimental mindset, and a willingness to push the boundaries to get patients faster access to treatments.

How to Apply

Apply now and take the first step in your career as a Clinical Trial Regulatory Lead at Roche.

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