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Regulatory Affairs Specialist

3 months ago

Mississauga, Ontario, Canada F. Hoffmann-La Roche Gruppe Full time

Company Overview

F. Hoffmann-La Roche Gruppe is committed to fostering diversity, equity, and inclusion, reflecting the communities we serve. We recognize that diversity is vital for success in the global healthcare landscape. Inclusion is essential for understanding the diverse healthcare needs of individuals. At Roche, every voice is valued, and we share a collective passion for delivering exceptional care.

Position Summary

Job Title: Regulatory Affairs Associate

Division: Medical Regulatory Affairs

Location: Mississauga Campus

Our mission is to innovate and advance science to ensure equitable access to healthcare for current and future generations. We aim to create a world where individuals can spend more time with their loved ones, which is the essence of Roche.

The Regulatory Affairs Chapter is dedicated to facilitating quicker access to improved patient outcomes. Our strategic focus encompasses the preparation, submission, and acquisition of authorizations for clinical trial applications, New Drug Submissions, and new indications. We also engage with external partners to influence regulatory policies that remove barriers, enabling faster access to essential medications and therapies.

The role of Regulatory Affairs Associate is pivotal within the Regulatory Affairs Chapter, requiring strategic collaboration across local and global networks to submit time-sensitive safety and chemistry and manufacturing (CMC) documents to Health Canada. This position also involves leading special projects aimed at enhancing processes, managing change, and participating in regulatory consultations and modernization initiatives.

Key Responsibilities
  • Oversee the planning, strategizing, preparation, and management of timely approvals for safety-related submissions, including safety label updates, Risk Management Plan maintenance, and reporting of foreign actions.
  • Manage the planning and execution of chemistry and manufacturing (CMC) submissions that impact critical product documentation, including the Certified Product Information Document (CPID) and Yearly Biologics Product Report (YBPR).
  • Facilitate pre-submission meetings with Health Canada as necessary.
  • Review product packaging artwork for compliance with Canadian regulations.
  • Support the review of promotional materials.
  • Maintain proficiency in internal regulatory systems and compliance tracking tools to efficiently execute daily tasks and support cross-functional processes.
  • Engage actively with the Regulatory Affairs Associate team and contribute to a collaborative environment.
  • Lead initiatives to improve regulatory processes for more efficient submissions.
Qualifications
  • Bachelor's Degree in a science-related discipline.
  • 3-5 years of experience in Regulatory Affairs.
  • Experience in the pharmaceutical or biotech sector, particularly in Regulatory Affairs or Quality Departments.
  • In-depth knowledge of Health Canada regulations and guidelines; familiarity with EU and FDA regulations is advantageous.
  • Proficient in Microsoft Office and Google Suite.
Preferred Skills
  • Pharmacy degree or a Master's degree/Graduate certificate in Regulatory Affairs.
  • Strong communication and problem-solving abilities.
  • Experience in process management and the ability to meet tight deadlines.
  • Proven ability to collaborate effectively within a team.
  • Demonstrated enterprise mindset and capability to work across cross-functional areas in a dynamic environment.

Note: Relocation benefits are not available for this position.

About Roche

At Roche, over 100,000 individuals across 100 countries are advancing the frontiers of healthcare. Our collaborative efforts have established us as one of the world's leading research-focused healthcare organizations. Our success is driven by innovation, curiosity, and a commitment to diversity.

Roche Pharma Canada employs over 850 individuals at its Mississauga facility, which promotes collaboration and reflects Roche's innovative culture.

Roche is an Equal Opportunity Employer.