Clinical Trial 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

A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come.

Creating a world where we all have more time with the people we love.

That’s what makes us Roche.

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
  
  

Relocation benefits are not available for this job posting.

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.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

As of January 4, 2022, Roche requires all new employees who work in Canada to be fully vaccinated against COVID-19 on the date they take office. This requirement is a condition of employment at Roche that applies regardless of whether the position is on a Roche campus or remotely. If you have a valid reason for not being fully immunized, which is limited to certain specific medical reasons or other valid reasons protected by applicable human rights laws, you may request an exemption and / or adaptation measures regarding this vaccination requirement.

Roche is an Equal Opportunity Employer.