Pharma Technical Regulatory ( PTR) Regulatory Affairs Intern

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

In this role you are contributing to the preparation and filing of the CMC (chemistry manufacturing & controls) component of regulatory submissions to meet global filing data and timeline requirements, the sustainment of regulatory compliance at manufacturing sites, and the representation of PTR within internal functions and external groups. The focus of this role is on providing support to global regulatory teams focused on CMC-development leading to successful global commercial registration and/or effective management of post-approvals changes and product lifecycle activities including dossier preparation.

The Opportunity:

• Lead the creation and submission of top-tier CMC regulatory documents to global health authorities, aligning with cGMP, Roche corporate standards, and regulatory requirements
• Facilitate seamless cross-functional collaboration and escalate issues as needed to ensure smooth operations
• Oversee the completion of cross-functional PTR deliverables, ensuring all assignments delegated by the Technical Regulatory Leader (TRL) are accurate, thorough, high-quality, and timely
• Keep the TRL/Squad fully informed about project status, potential submission risks, and impacts on regulatory strategies and timelines
• Contribute to regulatory excellence by identifying improvement opportunities, mitigating risks, and supporting continuous enhancement of processes
• Assist in product-related maintenance and Quality System activities, such as health authority commitments, inspections, and discrepancy assessments
  
  

Who you are:

• Bachelor’s Degree in life science disciplines and related fields
• You are currently enrolled in a Masters in Biomedical Discovery and Commercialization or Masters in Biotechnology program
• Demonstrates strong written and verbal communication skills
• Gather information, think through problems logically, and make timely decisions
• Achieves multiple tasks and goals on time while showcasing learning agility, teamwork, collaboration, and decision-making skills in new work environments
  
  

Additional Information:

Location: Hybrid, Based in Mississauga (minimum 3 days in the office)

Hours: full-time (35 hours per week)

Length: This position is a 12-month work term (full-time) and is expected to begin in January 2025

Relocation benefits are not available for this job posting.

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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.