MS Microbiology Jobs at AbbVie | Apply Now For The Regulatory Affairs Associate Role
AbbVie, a global leader in pharmaceuticals and biotechnology, is hiring a Regulatory Affairs Associate in Montreal, Quebec. This full-time role offers life science professionals the opportunity to work on regulatory submissions, compliance, and interactions with health authorities while contributing to groundbreaking therapies in immunology, oncology, neuroscience, eye care, and other areas. Join AbbVie and be part of a workplace recognized as one of the Best Workplaces in Canada.
- Job Position: Regulatory Affairs Associate
- Location: Montreal, Quebec, Canada
- Job ID: R00133850
About the Company
AbbVie is a global biopharmaceutical company dedicated to discovering and delivering innovative medicines that address serious health issues today while tackling tomorrow’s medical challenges. With a strong presence across various therapeutic areas, including immunology, oncology, neuroscience, eye care, virology, women’s health, gastroenterology, and aesthetics, AbbVie continues to make a remarkable impact on patients’ lives worldwide.
Job Description
The Regulatory Affairs Associate will support and lead regulatory submissions to Health Canada, ensuring compliance with the Food and Drugs Act and Regulations. This role involves working closely with global and affiliate stakeholders across commercial, medical, R&D, pharmacovigilance, and market access teams. The Associate will also be responsible for reviewing labels, managing regulatory operations, entering data into electronic management systems, and performing other regulatory-related activities.
Key Responsibilities
- Prepare, support, and manage regulatory submissions, including clinical trial applications, new drug submissions, supplemental submissions, notifiable changes, and device submissions.
- Assist in the evaluation of filing documents to ensure conformance with Health Canada guidelines.
- Prepare pre-submission meeting materials and presentations for Health Canada.
- Collaborate with global regulatory teams and provide Canadian regulatory guidance.
- Work with Global Labelling Management on artwork development and updates.
- Enter submission documents into electronic data management systems.
- Manage regulatory activities, including special access program requests.
- Support SOP reviews and updates for Regulatory Affairs processes.
- Stay updated on revisions to the Canadian Food and Drugs Act and related policies.
- Review and submit mandatory medical device problem reports as required.
Qualifications
- Education: Bachelor’s degree in Pharmacy, Biology, Pharmacology, or related Life Sciences.
- A Master’s or Doctorate in Biochemistry, Biology, Microbiology, Toxicology, Pharmacology, or an MBA is considered an asset.
- Experience: 1–3 years in the pharmaceutical industry.
- Working knowledge of Health Canada submission processes.
- Experience with biologics, small molecules, medical devices, or clinical trial applications is an asset.
- Understanding of the Canadian Food and Drugs Act and Regulations.
- Proficiency in electronic regulatory submissions and computer applications.
- Strong teamwork, communication, and problem-solving skills.
- Advanced English proficiency is required for global collaboration.
Keywords: Regulatory Affairs Associate, Montreal, Quebec, Health Canada, Pharmaceuticals, AbbVie, MS Microbiology Jobs at AbbVie, Full-time, Job Postings.
