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Regulatory Affairs Specialist

2 months ago

Mississauga, Ontario, Canada Roche Full time
About the Role

At Roche, we are committed to fostering a culture of diversity, equity, and inclusion, reflecting the communities we serve. As a Regulatory Affairs Specialist - CMC Development, you will play a critical role in the preparation and filing of CMC components of regulatory submissions, ensuring compliance with global filing data and timeline requirements.

Key Responsibilities
  • 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.
Requirements
  • Bachelor's Degree in life science disciplines and related fields.
  • Currently enrolled in a Master's in Biomedical Discovery and Commercialization or Master's 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.