Clinical Trial Regulatory Lead

Social network you want to login/join with:

The Pharma Development Regulatory (PDR) organization develops and maintains the licensees that permit Roche to market and sell its life improving therapies worldwide. We are the stewards of the safety and efficacy of medicines, collaborating with regulators of every country in which Roche does business to help them understand our products’ clinical value. We also work across industry and regulators to continually evolve regulatory policy.

As a Clinical Trial Regulatory Lead (CTRL), you will lead the clinical trial regulatory strategy and submissions globally (ex US/China/Japan) for molecules and medical devices. The CTRL engages across the early research and development functions (REDs), affiliates, product development, and technical regulatory to develop and realize clinical trial submission strategies, build regulatory submissions, and deliver fit-for-purpose solutions to achieve organizational goals and objectives.

A CTRL also enables the development of organizational and people capabilities of the future. CTRLs lead, contribute to, and optimize the delivery of projects and initiatives to the organization both on the molecule and molecule enabling portfolio.

The CTRL sits in a dynamic and multifaceted environment and requires strong global clinical trial regulatory knowledge (both for molecule and medical devices), an innovative and experimental mindset, and a willingness to push the boundaries to get patients faster access to treatments.

In this position you:

1. Provide expert advice and regulatory insights to the organization on external and internal requirements for clinical study (molecule and device) procedures and monitor the regulatory landscape for changes.
2. Lead the regulatory procedure for Clinical Studies (molecule and device) submissions.
3. Engage in dialogue with health authorities to ensure efficient approvals of submissions and shape the external regulatory environment.
4. Lead clinical study (molecule and device) submissions to Health Authorities globally (ex US, China, Japan) including strategy, compilation, and lifecycle management.
5. Lead/Participate in cross-organizational/enterprise level projects and initiatives.
6. Partner with global policy to shape the external regulatory environment.
7. Invest in your own learning and development, in addition to coaching and mentoring the development of other team members.
8. Identify and pursue opportunities optimizing the clinical study (molecule and device) processes.

You are someone to bring the following knowledge, skills, and abilities:

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, and 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 (CTRL).

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.

#J-18808-Ljbffr