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Added 7 mins ago
Mechanical Designer
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Full-time
Employer Matched RRSP (Registered Retirement Savings Program)
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Health Care Aide | Permanent, Full-Time | Evenings 3:00-11:30pm (5days on, 2off, 5days on, 3off)
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Full-time
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AbbVie

Senior Manager, Regulatory Affairs

Montreal, QC, Canada

Job type: Full-time
Apply by: Oct 3, 2026
Education: Bachelor’s degree
Posting language: English
Posted: Sep 23, 2026

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Original job description

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health, and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

Our Great Place to Work® Certification highlights our dedication to cultivating a high-trust, and inclusive culture for all.

At AbbVie, you won't just have a job, you’ll have the opportunity to unlock a bright future, because we're not just a workplace; we're a world of possibilities.

Difference makers wanted. Apply now!

The Senior Manager, Regulatory Affairs (SrMRA) is responsible for the direction, management and oversight of a team of Regulatory Affairs professionals and their respective activities. The Senior Manager, Regulatory Affairs also provides strategic input and actively supports the filing and approval with Health Canada of various types of regulatory submissions in support of AbbVie’s development and marketed products portfolio, including medical devices. These responsibilities are carried out in collaboration with internal stakeholders (e.g., AbbVie affiliate and Global Regulatory Affairs, Commercial, Market Access, Medical Affairs, Pharmacovigilance, and Research & Development teams). The SrMRA actively supports brand teams on assigned projects, by understanding all aspects of the business, and by sharing regulatory-related decisions, initiatives, issues, and updates with team members in a timely fashion. The SrMRA is also responsible for communicating and ensuring that the Lead, Regulatory Affairs is advised on key issues and updates discussed at the early pipeline touchpoints, brand teams, New Product Introduction (NPI), and Launch Readiness Review (LRR) meetings.

Combining knowledge of scientific, regulatory and business strategies, the Senior Manager, Regulatory Affairs ensures the advancement and commercialization of AbbVie’s products while maintaining compliance with Health Canada’s regulatory policies, regulations and guidance documents.

Key responsibilities

Strategically support and/or prepare the filing, approval, and post-approval activities of several types of regulatory submissions including, but not limited to, clinical trial application activities, new drug submissions supplemental new drug submissions, notifiable changes, and medical device-related submissions.
Hold self and all direct reports accountable for regulatory-related projects and ensure regulatory submission filing and approval timelines are met.
Supervise, manage, support and mentor direct reports.
Conduct mid- and year-end performance evaluations with each direct report and provide timely constructive feedback on a regular basis.
Review and assist in the evaluation of regulatory submission documents for conformance with Health Canada’s Food and Drugs Act, regulations, policies, and guidelines.
Support the preparation and conduct of pre-submission meetings with Health Canada. This includes, but is not limited to, the preparation of pre-meeting materials and presentations.
Consult with the AbbVie Global Regulatory team to define filing strategies and provide Canadian regulatory guidance for assigned projects.
Actively support and participate in brand team meetings, as applicable.
Actively support and assist in early pipeline touch point meetings, as applicable.
Actively participate in new product introduction (NPI) and launch readiness review (LRR) meetings and provide timely regulatory updates, as applicable.
Work with the AbbVie Global’ Strategic Labelling team, the AbbVie Global Regulatory Affairs team, the Global Labelling Management team, and the affiliate brand teams to develop competitively differentiated Canadian labels and label artwork.
Manage RA activities related to product in-licensing, divestitures and/or acquisitions.
Oversee and ensure the timely data entry of all submission documents into the Canadian Affiliate and AbbVie Global’s electronic data management systems.
Support or manage regulatory activities related to special access program (SAP) requests, access to information requests and establishment licencing activities
Read, understand and comply with assigned trainings and ensure direct reports complete assigned trainings within pre-established deadlines.
Keep track of revisions and updates made to the Canadian Food and Drugs Act; regulations and related policies and guidelines as these pertain to Regulatory activities.
Actively support the review and preparation of comments to new Health Canada “proposed/draft” Guidance’s and policies open for consultation, and communicate to management accordingly.
Support the review and impact assessment of AbbVie Global’s Standard Operating Procedures (SOPs) and update local SOPs, as applicable.
Be actively involved in AbbVie Global’s regulatory initiatives, as applicable.
Actively support and lead internal and external inspections / audits.
Advise management of all regulatory-related activities, especially those that may impact the outcome of filings and/or approvals.
Operate in compliance with local regulations and company policies and procedures.

Qualifications

Education / Experience required

Bachelor’s degree in Pharmacy, Biology, Pharmacology, or related Life Sciences is required
Preferred Master of Science degree or Doctorate in Biochemistry, Biology, Microbiology, Chemistry, Toxicology, Pharmacology or in Management, such as a Master of Business Administration degree, is considered an asset.
Minimum of ten years of experience in the pharmaceutical industry
Minimum of four years of experience in leading a team of professionals
Proven success in the preparation, filing, and approval of various submission types with Health Canada, and established negotiation and networking skills
Developed expertise in the field of Regulatory Affairs, and a good understanding of the Business environment, products, and service areas
Experience with Biologics, small molecules, medical devices, quality-related changes, and clinical trial applications are an asset
Developed working knowledge and understanding of the Canadian Food and Drugs Act and Regulations, its policies, and related guidelines, including a basic understanding of the FDA and EMA, CHMP, MHRA regulatory requirements.
Experience in leading and developing regulatory strategies
Excellent organizational, project management, negotiation, and interpersonal skills
Comfortable and efficient working in a matrix environment
Computer proficient
Experience with electronic regulatory submissions.

Essential Skills and Abilities

AbbVie aims to offer a French-speaking workplace in Quebec and has made efforts to limit English requirements. However, advanced English skills are essential for this role because the position involves working with English-speaking employees, clients, and regions outside Quebec.
Team player with experience in managing, coaching and mentoring employees
Ability to take key action and demonstrate behavioural anchors that support all AbbVie core and leadership competencies.

Additional Information

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 is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

Workday Global Grade: 18

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More about this job

Responsibilities

The Senior Manager, Regulatory Affairs directs and oversees a team of professionals while providing strategic input for regulatory filings and approvals with Health Canada. They collaborate with internal stakeholders to ensure product commercialization remains compliant with regulatory policies and guidelines.

Requirements

Candidates must hold a bachelor's degree in a life sciences field and possess at least ten years of pharmaceutical industry experience. A minimum of four years in a leadership role and proven success in managing Health Canada regulatory submissions are required.

Skills

Regulatory Affairs
Health Canada Regulations
Team Leadership
Project Management
Strategic Planning
Regulatory Submissions
Clinical Trial Applications
Drug Submission
Medical Devices
Mentoring
Stakeholder Management
Compliance
Labeling Strategy
Negotiation
Networking
Pharmaceutical Industry

Visa sponsorship

Not detected in the job text

Keywords

Regulatory Affairs
Health Canada
Pharmaceutical
Biologics
Small Molecules
Medical Devices
Clinical Trial Application
New Drug Submission
Compliance
Strategy
Leadership
Project Management
Labeling
Quality Assurance
Pharmacovigilance
Market Access
Research & Development
Food and Drugs Act
Electronic Data Management
Audits
Inspections
Mentoring
Stakeholder Management
Regulatory Strategy
Launch Readiness
New Product Introduction
Divestitures
Acquisitions
Standard Operating Procedures
Life Sciences

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