Pharma Technical Regulatory Submission Intern
About The Position
At Roche, we foster a culture where individuality is embraced, and open dialogue is encouraged. We aim to prevent, stop, and cure diseases, ensuring global access to healthcare. As a Pharma Technical Regulatory Submission Intern in Mississauga, you will support the delivery of high-quality regulatory submissions to health authorities worldwide. You will collaborate with cross-functional experts to manage critical submission processes and maintain global compliance for our life-saving portfolio. This 12-month internship provides an opportunity to develop expertise in regulatory operations, project management, and data systems, contributing to positive patient outcomes.
Requirements
- Currently enrolled in a Master’s degree in Biotechnology, Biomedical Discovery and Commercialization, or a closely related field, with a completed Bachelor’s degree in life sciences.
- Knowledgeable in pharmaceutical/biotechnology industry operations and drug development processes.
- Highly detail-oriented with proven abilities in data consistency, proofreading, and language mechanics.
- Tech-savvy and adaptable, with a strong drive to leverage digital tools for efficient workflows.
- An organized team player and strong communicator who thrives under pressure and dynamic priorities.
Responsibilities
- Prepare global (CMC) regulatory submissions, including Module 3 CTD dossiers and electronic formatting standards.
- Manage regulatory information systems and documentation across diverse health authority submission types.
- Create and track project timelines to drive operational excellence and streamline regulatory workflows.
- Apply data quality management practices using core business IT systems to support data-driven content management.
- Collaborate with cross-functional technical development teams to provide clear regulatory guidance.
- Participate in agile methodologies (such as Scrum) to support continuous improvement initiatives.
Benefits
- Relocation benefits are not provided.
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What This Job Offers
Job Type
Full-time
Career Level
Intern
