Regulatory Affairs Associate Job – at AbbVie, Apply Now!
Are you ready to bring your regulatory expertise to one of the world’s most innovative biopharmaceutical companies? AbbVie is hiring a Regulatory Affairs Associate on a temporary 11-month contract in Montreal, Canada. This is a career-defining opportunity for life sciences professionals with 1–3 years of experience in regulatory submissions to Health Canada. Join a passionate global team working across key therapeutic areas like immunology, oncology, and neuroscience, driving regulatory excellence that impacts patient lives.
- Job Title: Regulatory Affairs Associate (Temporary Contract)
- Location: Montreal, QC
- Function: Research & Development
- Job Type: Full-Time
- Duration: 11 Months
- Job ID: R00131359
About The Company
AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.
Job Description
As a Regulatory Affairs Associate at AbbVie Canada, you will support and lead regulatory submissions, liaise with Health Canada, and help navigate post-approval activities. Working cross-functionally with R&D, market access, and global labeling teams, this role ensures that products are registered and maintained in compliance with Canadian regulations.
Key Responsibilities:
- Prepare, file, and manage regulatory submissions (e.g., CTAs, NDS, NCs, device-related dossiers).
- Liaise with Health Canada and support pre-submission meetings.
- Collaborate with Global Regulatory teams and provide local Canadian guidance.
- Manage labelling updates and artwork reviews with Global Labelling Management.
- Maintain accurate records in the electronic data management system.
- Monitor Canadian regulatory updates and ensure SOP compliance.
- Review and submit mandatory reports related to medical devices.
- Support SAP requests and access to information requests.
- Ensure compliance with the Canadian Food and Drugs Act, policies, and AbbVie procedures.
Qualifications
- Education:
- Bachelor’s in Pharmacy, Biology, Pharmacology, or related Life Sciences.
- A master’s or PhD in a relevant field (e.g., Biochemistry, MBA) is an asset.
- Experience:
- 1–3 years in the pharmaceutical industry, regulatory affairs.
- Knowledge of Canadian submission types (e.g., NDS, CTA, Biologics).
- Familiarity with Health Canada regulations and electronic submissions.
- Skills:
- Strong organizational and communication skills.
- Ability to work independently and collaboratively.
- Proficient in English (spoken and written) due to global team coordination.
- Fluency in French is an asset, but not mandatory.
- Click here to learn more about reasonable accommodations for US & Puerto Rico applicants.
- AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities, and members of visible minorities to apply.
- AbbVie is an equal opportunity employer and encourages women, Aboriginal people, persons with disabilities, and members of visible minorities to apply.
Keywords: Regulatory Affairs, Associate, Job Opportunity, Temporary Contract, Montreal, Research & Development, AbbVie
