The ideal candidate will work from our St-Laurent, QC offices.

The Regulatory Affairs (RA) Associate is responsible for supporting or leading the preparation, filing, negotiation and approval of various types of regulatory submissions to Health Canada in support of AbbVie’s drugs and medical devices. These responsibilities are carried out in collaboration with key global and affiliate AbbVie stakeholders (e.g., regulatory, commercial, market access, medical, pharmacovigilance, and research & development teams). 

In addition, the RA Associate is also expected to manage other regulatory-related activities, including but not limited to label reviews, and administrative responsibilities related to regulatory filings (i.e., data entry into the electronic data management system). The Senior RA Associate may also be responsible for tasks in relation to regulatory operations. 

Key Responsibilities: 

• Prepare and/or support the filing, approval, and post-approval activities of various types of regulatory submissions including, but not limited to, clinical trial application activities, new and supplemental drug submissions, notifiable changes, and medical device-related submissions.
• Under the supervision of the RA Manager or RA Project Lead, review and assist in the evaluation of supportive filing documentation for conformance with Health Canada’s Food and Drugs Act and Regulations, policies and guidelines.
• Support the preparation of pre-submission meetings with Health Canada. This includes, but is not limited to, the preparation of pre-meeting materials and presentations.
• Liaise with the Global regulatory team and provide Canadian regulatory guidance for assigned projects, as applicable.
• Work with Global Labelling Management to develop, update and approve label artwork.
• Ensure the timely data entry of all submission documents into the Affiliate and global electronic data management systems.
• Support or manage regulatory activities such as special access program requests and access to information requests.
• Support the review and impact assessment of global Standard Operating Procedures (SOPs) and update local Regulatory Affairs SOPs, as applicable.
• Read, understand, and comply with assigned trainings and complete within pre-established deadlines.
• Keep abreast of revisions to the Canadian Food and Drugs Act and Regulations, related policies and guidelines as these pertain to RA activities.
• Keep immediate supervisor informed on all RA-related activities.
• Operate in compliance with local regulations and company policies and procedures.
• Review and submit mandatory problem reports in compliance with the Canadian Medical
• Device Regulations as necessary