Clinical Trials Regulatory Lead

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

The Position

As a Clinical Trial Regulatory Lead (CTRL) you will enable the global Regulatory function to deliver data and insights about our medicines by leading clinical trial regulatory submissions worldwide.  The CTRL engages across the early research and development functions (REDs), affiliates, product development (PD) and technical regulatory to develop and realize clinical trial submission strategies, build regulatory submissions and deliver fit-for-purpose solutions to achieve Regulatory, PD and Roche goals and objectives.

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

We are an agile team with an innovative operational model with generic job descriptions allowing our people to explore their talent and learn across many areas.

The Opportunity: 

• Serve as the first point of contact for all regulatory clinical trial expertise, providing critical guidance and insights.

• Function as a partner by challenging existing strategies, connecting the dots across different projects, and taking smart risks to propel the organization forward.

• Improve efficiencies by demonstrating cross-study learnings and applying them to new clinical trials, thereby streamlining processes.

• Offer comprehensive insights into global clinical trial regulations, advising collaborators on regulatory requirements and changes to ensure compliant and efficient study execution.

• Adopt and translate changes in the external regulatory landscape for stakeholders, ensuring that internal processes are continually aligned with current regulations.

• Enable the business to expedite the delivery of clinical trial activities through expert regulatory advice, proactive monitoring, and efficient handling of submissions.

• Lead global clinical study submissions to health authorities, engage in regulatory dialogues, shape the external regulatory environment, and invest in personal and team development through continuous learning, coaching, and mentoring.

Who you are:

• You bring 1-3 years of experience and a bachelor's degree 

• You are keen to develop regulatory insights through your experience, regulatory and scientific knowledge to determine solutions and address 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 (e.g. health authorities, CROs, IVD manufacturers) customers 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 (e.g. CTR)

• You work effectively to share responsibility as a team member in a customer focused environment. You share information, knowledge and guidance (e.g. mentoring and onboarding new team members). You approach work with a positive and curious demeanor.

In exchange we provide you with:

• Development opportunities: Roche is rich in learning resources. We provide constant development opportunities, free language courses & trainings, the possibility of international assignments, internal position changes and the chance to shape your own career.

• Excellent benefits & flexibility: competitive salary and cafeteria package, annual bonus, Private Medical Services, Employee Assistance Program, All You Can Move Sportpass, coaching / mentoring opportunity, buddy program, team buildings, holiday party. We also ensure flexibility, to help you find your balance: home office is a common practice (2 office days/week, and we provide fully remote working conditions within Hungary).

• A global diverse community, where we learn from each other. At Roche, we cooperate, debate, make decisions, celebrate successes and have fun as a team. Our leadership is very focused on people, creating a strong, inclusive culture, so you always have the chance to share your opinion.

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Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

The Roche Services & Solutions as well as People Support Solutions organisations located in Budapest provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the EMEA region. Today Roche employs altogether around 2000 employees in Hungary.