Clinical Trial Regulatory Lead
4 weeks ago
We are seeking a highly skilled Clinical Trial Regulatory Lead to join our team. As a key member of our Regulatory function, you will play a critical role in enabling the global delivery of data and insights about our medicines by leading clinical trial regulatory submissions worldwide.
The successful candidate will engage across early research and development functions, 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 Regulatory, PD, and Roche goals and objectives.
Key Responsibilities:
- Provide critical guidance and insights as the first point of contact for all regulatory clinical trial expertise.
- Partner with stakeholders to challenge existing strategies, connect the dots across different projects, and take 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.
Requirements:
- 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 influence directly or indirectly the internal and external 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 work effectively to share responsibility as a team member in a customer-focused environment.
About Us:
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.
Roche is an Equal Opportunity Employer.
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