Regulatory Clinical Trials Associate

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The Position

Job Title : Regulatory Clinical Trials Associate

Location: Canada Pharma Campus - Mississauga - Hybrid

Duration: 18 months

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.

The Regulatory Affairs Chapter is committed to ensuring patients have access to improved outcomes more quickly. Our strategic focus is on building, submitting, and obtaining approvals for clinical trial applications, new drug submissions, and new indications. Additionally, we collaborate with external partners to shape regulatory policies that eliminate barriers, enabling faster access to medications and therapies for patients.

The Regulatory Clinical Trial Associate Team is an integral part of the Regulatory Affairs chapter working in a fast paced environment, enabling Canadian patients to participate in Roche clinical trials within our broad portfolio. The team is responsible for filing Clinical Trial Applications (CTAs) and related submissions to Health Canada in adherence to local regulations and guidance. We also lead special projects aimed at enhancing processes, driving change management, and actively participate in regulatory consultations and modernization initiatives.

We are currently seeking a collaborative and motivated individual to join our team as a Regulatory Clinical Trials Associate. In this role, you will be responsible for Clinical Trial Submissions, including the planning, strategy, and timely preparation and approval of Clinical Trial Applications (CTAs) and Medical Device Investigational Testing Authorizations (ITAs) to Health Canada. Your responsibilities will also involve actively participating in cross-functional meetings for study submissions, collaborating closely with local and global stakeholders, contributing to the development and maintenance of local Standard Operating Procedures (SOPs), process maps, and operating guides aligned with Canadian regulatory requirements. Additionally, you will stay updated on relevant regulatory systems used for CTAs/ITAs and support cross-functional processes.

The Opportunity 

• You are accountable for planning, strategizing, and preparing timely Clinical Trial Application (CTA) and Medical Device Investigational Testing Authorization (ITA) submissions to Health Canada, including all types of submissions throughout the process.  

• You are supporting preparation and execution of pre-submission meetings with Health Canada as necessary.

• You are responsible for preparing submissions and obtaining Health Canada  authorizations for Dear Investigator Letters (DILs) and other urgent safety notifications pertaining to CTAs.

• You maintain up-to-date knowledge of, and work within, internal regulatory systems and platforms used for CTA/ITA compliance tracking to efficiently execute day-to-day activities and support cross-functional processes.

• You are actively engaging with the CTA team and the Regulatory Affairs chapter, comfortable speaking up, and challenging when necessary.

• You are working collaboratively, sharing expertise within the Regulatory Affairs chapter, and across the organization, to eliminate silos and duplication, ensuring efficient use of skills.

• You are leading and managing implementation of improvements to regulatory processes for more efficient and successful clinical trial submissions.

Who you are

• You hold a Bachelor’s Degree in a science-related field.

• You possess a minimum of 1 year work experience in Regulatory Affairs.

• You have experience in the pharmaceutical/biotech industry in Regulatory Affairs or Quality Department.

• You have in-depth knowledge of Health Canada regulations and guidelines. Additionally, knowledge of the EU and FDA regulations and guidelines are an asset, to understand where the Canadian regulations align or contrast.

• You have the necessary knowledge of Microsoft Office and Google Suite.

Preferred

• You hold a Graduate certificate in Regulatory Affairs.

• You demonstrate strong communication and problem-solving skills.

• You have experience in process management, planning and strong ability to meet tight deadlines.

• You demonstrate the ability to collaborate and work as a team.

• You demonstrate an enterprise mindset and the ability to work effectively across cross-functional areas in a fast-paced environment.

Relocation benefits are not available for this position.

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.