Regulatory Affairs Associate

at  Roche

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
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche.
The Regulatory Affairs Chapter is committed to ensuring patients have access to improved outcomes more quickly. Our strategic focus is on building, submitting, and obtaining authorizations for clinical trial applications, New Drug Submissions, and new indications. Additionally, we collaborate with external partners to shape regulatory policies that eliminate barriers, enabling faster access to medications and therapies for patients.
The Regulatory Affairs Associate role is an integral part of the Regulatory Affairs Chapter working strategically and collaboratively across local and global networks to file time-sensitive safety and chemistry and manufacturing (CMC) submissions to Health Canada. This role is also responsible for leading special projects aimed at enhancing processes, driving change management, and actively participating in regulatory consultations and modernization initiatives.
We are currently seeking a collaborative and motivated individual to join our team as a Regulatory Affairs Associate. In this role, you will be responsible for the strategic planning, and timely preparation and approval, of post-authorization changes (Supplemental New Drug Submissions, Notifiable Changes, Level III/IV changes), and support various components of New Drug Submission filings. Your responsibilities will also involve collaborating and actively participating with local and global cross-functional submission teams, and contributing to the development and maintenance of local Standard Operating Procedures (SOPs), process maps, and operating guides aligned with Canadian regulatory requirements. Additionally, you will stay updated on relevant systems used for regulatory filings and support cross-functional processes.

Please refer the Job description for details