Clinical Trial Regulatory Lead

Roche; Basel; Vor Ort; CHF 100’000 - 140’000; Vollzeit

Zusammenfassung

An established industry player is seeking a Clinical Trial Regulatory Lead to spearhead global regulatory strategies for clinical trials involving innovative therapies. This pivotal role involves collaborating with diverse teams to ensure compliance with evolving regulations and facilitating timely approvals from health authorities. The ideal candidate will possess a robust understanding of clinical trial regulations and a commitment to optimizing processes for patient access to treatments. Join a forward-thinking organization where your expertise will drive impactful change in the healthcare landscape.

Qualifikationen

• Strong knowledge of global clinical trial regulations for molecules and medical devices.
• Ability to influence stakeholders and manage global submissions.

Aufgaben

• Lead global regulatory strategy and submissions for clinical trials.
• Engage with health authorities to facilitate approvals.

Kenntnisse

Regulatory Strategy Development

Clinical Trial Regulations

Stakeholder Engagement

Project Management

GCP Principles

Communication Skills

Ausbildung

Degree in Life Sciences

PhD or equivalent experience

Tools

CTIS

Veeva Vault

Jobbeschreibung

The Position

Clinical Trial Regulatory Lead

The Pharma Development Regulatory (PDR) organization develops and maintains the licenses that permit Roche to market and sell its therapies worldwide. We ensure the safety and efficacy of medicines by collaborating with regulators globally and evolving regulatory policies.

As a Clinical Trial Regulatory Lead (CTRL), you will lead the global regulatory strategy and submissions for clinical trials involving molecules and medical devices (excluding US, China, Japan). You will work across research and development, affiliates, and technical regulatory teams to develop submission strategies, compile regulatory documents, and deliver solutions aligned with organizational goals.

The CTRL also focuses on developing organizational and team capabilities, leading and optimizing project delivery across the portfolio.

This role requires strong knowledge of global clinical trial regulations for both molecules and medical devices, an innovative mindset, and a willingness to challenge boundaries to accelerate patient access to treatments.

In this position you will:

1. Provide expert advice on clinical study regulatory requirements and monitor changes in the regulatory landscape.
2. Lead regulatory procedures for clinical study submissions.
3. Engage with health authorities to facilitate approvals and influence regulatory policies.
4. Manage global clinical study submissions, including strategy, compilation, and lifecycle management.
5. Participate in cross-organizational projects and initiatives.
6. Collaborate with global policy teams to shape external regulatory environments.
7. Invest in personal learning and development, and mentor team members.
8. Identify opportunities to optimize clinical study processes.

Required knowledge, skills, and abilities:

• Develop regulatory insights through experience and scientific knowledge to solve problems and determine solutions.
• Assess priorities, adapt strategies, and seek process improvements, including digital solutions, while maintaining compliance and meeting deadlines.
• Influence stakeholders at various levels, including health authorities, CROs, and manufacturers, to reach consensus and achieve objectives.
• Communicate effectively in multicultural, multifunctional environments.
• Lead teams through submission activities to meet timelines and goals.
• Share responsibility, mentor, and onboard new team members.
• Possess knowledge of EU clinical trial regulations, IVDR, and other relevant legislation in Europe and globally.
• Have a good understanding of GCP principles and experience with Clinical Trial Information Systems like CTIS and Veeva Vault.