Job Description

The Position

Intern/Co-op Regulatory Affairs Associate

Length: 12 months and full time.

Location: Hybrid / Mississauga, ON.

Job description

At Roche, we deliver medical solutions and develop innovations for the future in order to transform patients\xe2\x80\x99 lives. We believe that good business means a better world and we commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all.

This is an exciting internship opportunity to join the team located at the Mississauga, Canada site within the global Pharma Technical Regulatory (PTR) organization at Roche. PTR provides technical regulatory oversight for global submissions, changes assessments, and discrepancies. PTR plays a critical role in maintaining the regulatory compliance of Roche\xe2\x80\x99s global portfolio of products.

In this position, you will interact with regulatory and technical subject matter experts from different sites within the company in order to coordinate and prepare document packages for regulatory submissions for new and/or mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies.

You will gain knowledge in the following areas:

• Principles of Regulatory Affairs and develop an understanding of the regulatory requirements for bringing medicines to patients.
• Project management of regulatory submissions.
• Become familiar with Regulatory strategy.
• Become familiar with documentation in a regulated, GMP environment.
• Learn about agile ways of working through opportunities to work with different squads and expert groups within PTR.
• Improve interpersonal and communication skills by participating in global, cross-functional project teams.

Specific responsibilities for this position may include:

• Assist in preparing the Chemistry and Manufacturing Controls (CMC) sections [ie. Module 3] of regulatory submissions.
• Facilitate responses to requests for information from countries around the world for existing products.
• Collaborate with and/or provide consultancy to key stakeholders to provide timely regulatory input and guidance to technical development/product teams to achieve company objectives.
• Any other responsibilities as required.
• There will also be opportunities to support other Pharma Technical (eg. Quality, Supply Chain, Development, Strategy) teams within Mississauga through the FutureWorks program based on time and interest.

Who you are

• Currently enrolled at a STEM Master\xe2\x80\x99s program (MBiotech UofT OR Master of Biomedical Discovery & Commercialization MBDC McMaster program preferred).
• Must be highly motivated and able to work independently as well as in a team.
• Strong communication, organizational and analytical skills.
• Ability to drive activities; work under pressure and to tight timelines.

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\xe2\x80\x99ve become one of the world\xe2\x80\x99s 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.

Roche