Regulatory Affairs Intern
Mississauga, CANADA IT development
Job description
The Position
The Regulatory Affairs Intern works collaboratively with the Regulatory Affairs team, internal networks (locally and globally), and Health Canada. This position provides an opportunity to support various types of regulatory applications, and to assist with departmental initiatives.
All Roche employees are required to report any information they become aware of related to the safety and / or quality of Roche products, within one business day of awareness. Adverse events should be reported to Roche Canada Patient Safety (Drug Safety) and product complaints to Roche Canada Medical Information. Employees involved in clinical trial oversight will follow SOPs for routing events appropriately.
Job Accountabilities:
Regulatory Submissions:
Supports the Regulatory Affairs team in the preparation of various regulatory submissions to Health Canada (ie, Clinical Trial Applications and Amendments, Investigational Testing Authorizations, New Drug Submissions, Medical Device Applications, Supplemental New Drug Submissions, Notifiable Changes, and Level III Changes), and responses to Health Canada queries
Responsible for actively participating in cross-functional meetings for regulatory submissions, working closely with relevant local and global stakeholders (Product Development Regulatory, Pharma Technical Regulatory, Product Development Operations, GxP, etc.)
Accountable for keeping up-to-date with evolving Canadian Regulations to facilitate decision-making and ensure regulatory compliance
Systems / Process:
Contributes to the development and maintenance of Canadian Standard Operating Procedures (SOPs), process maps, and operating guides that are aligned to our Canadian regulatory requirements (Food and Drug Act and Regulations; Medical Device Regulations).
Maintains current knowledge on the relevant electronic document management systems used for regulatory projects to be able to efficiently execute day- to-day activities (eg. Regulatory Information Management System, Global Product Regulatory System, etc), and support cross-functional processes
Active contributor to departmental regulatory information-sharing framework (gDrives, gSites, One Archive, etc.)
Participation in departmental objectives pertaining to process optimization
Ways of Working:
The following principles are prioritized within the team
Offering help when you can; asking for help when you need it
Being actively engaged with the Regulatory Affairs team - feeling comfortable speaking up, challenging when appropriate
Working collaboratively and sharing expertise across the organization (locally and globally) to remove silos, duplication, ensuring efficient use of skills sets
Job Requirements:
Must hold a Bachelor’s Degree in Science
Must be currently enrolled in a post-graduate program in a relevant field (ie, Humber College’s Regulatory Affairs program; Seneca College’s Pharmaceutical Regulatory Affairs & Quality Operations program)
Must be available to work full-time (35 hours per week) during 12 months.
Strong interpersonal and communication skills
Strong problem-solving skills
Strong project management and planning skills
General understanding of Health Canada regulations and guidelines.
Microsoft Office and Google Suite skills are required
Additional Information
This position is a 12-month work term (full-time) and will begin in May 2024.
This internship position is located in Mississauga.
Our team follows a hybrid work structure (minimum 3 days per week in the office).
Relocation benefits are not available for this job.
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.