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Added 1 hour ago
Senior Product Manager, Accounting
Jobgether
Canada
Full-time
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Product Manager, Accounting based in Canada .
Added 2 hours ago
Product Manager, Business Transformation
FirstService Residential Canada
Vancouver, BC
Full-time
As a Product Manager, you will be responsible for the strategy, development, and success of our product(s). You will work closely with cross-functional teams including resident care,…
Added 2 hours ago
Category Manager
Food Basics
Toronto, ON · Etobicoke, ON
Full-time
Leads layout planning meetings with Merchandising and Operations VP's and DM's/Directors. Utilizes Spectra demographic research and internal sales data to steer strategy on a store by store…
Added 2 hours ago
Product Manager, Business Transformation
FirstService Residential Canada
Mississauga, ON
Full-time
As a Product Manager, you will be responsible for the strategy, development, and success of our product(s). You will work closely with cross-functional teams including resident care,…
Added 2 hours ago
Product Manager, Business Transformation
FirstService Residential Canada
Toronto, ON
Full-time
As a Product Manager, you will be responsible for the strategy, development, and success of our product(s). You will work closely with cross-functional teams including resident care,…
Added 2 hours ago
Absence, Time Tracking & Payroll Lead, BC Health Workday
Provincial Health Services Authority
BC · British Columbia, Canada
Full-time
…software solution as part of the BC Health Human Resources Strategy to transform HR services. Designed by Workday Canada, the new provincial platform will replace existing HR and payroll…
Added 4 hours ago
Nurse, Clinical Informatics Specialist
Sanya’k̓ula
Nanaimo, BC
Full-time
The Nurse, Clinical Informatics Specialist (CIS) reports to the Manager and provides consultation, facilitation and instruction on the design, optimization and integration of clinical…
Added 4 hours ago
Bilingual Senior Proposal & Sales Bid Manager (Retirement and Benefit Solutions)
TELUS Health
Montreal, QC
Full-time
The Sr. Proposal & Sales Bid Manager is responsible for the strategic oversight and end-to-end lifecycle of the bid process, often managing multiple high-value opportunity workstreams in…
Added 4 hours ago
IT Infrastructure Project Manager
Amphenol Communications Solutions
Markham, ON
Full-time
As an IT Project Manager, you will be responsible for planning, executing, and delivering projects focused on aligning global and local technology strategies for IT Infrastructure (Servers…
Added 4 hours ago
Enterprise Project Manager
peoplecare communities
Waterloo, ON
$90,000 to $120,000 CAD / year
Full-time
The Enterprise Project Manager leads and coordinates complex, cross-functional projects that advance peopleCare's organizational priorities. The role will focus primarily on new home…
Added 4 hours ago
Wellbeing Advisor
TC Energy
Calgary, AB
Full-time
Reporting to the Manager of Health Services, the Wellbeing Advisor will help advance TC Energy’s enterprise wellbeing strategy and bring our employee value proposition - Thriving together -…
Added 4 hours ago
Director, Digital Marketing & Web Experience
Varicent
Toronto, ON
You’ll have the opportunity to shape the function - leading a Senior Manager of Digital Marketing and Senior Web Developer, partnering with specialized agencies, and working closely with…
Added 4 hours ago
Director, Digital Marketing & Web Experience
Varicent
Toronto, ON
…leader in the 2025 Forrester Wave Report for SPM, 2023 Ventana Research Revenue Performance Management (RPM) Value Index, Gartner Peer Insights, 2024 Gartner SPM Market Guide, and G2. Our…
Added 5 hours ago
Data Scientist, Decisions - Mapping
Lyft
Toronto, ON
Degree in a quantitative field such as statistics, economics, applied math, operations research or engineering (advanced degrees preferred), or relevant work experience
Added 5 hours ago
Digital Product Owner
BMO
Toronto, ON · BMOPLACE
Full-time
Fosters a culture aligned to BMO purpose, values and strategy and role models BMO values and behaviours in all that they do.
Added 5 hours ago
Group Product Manager - Home Financing
BMO
Toronto, ON · BMOPLACE
Full-time
The Group Product Manager - Home Financing researches, defines, aligns, develops and accountable on the performance management and analytics with P&L (profit and loss) accountability for…
Added 5 hours ago
Global Investment Operations - Middle Office Senior Analyst
WTW
Toronto, ON
$70,000 to $80,000 CAD / year
Full-time
Our commitment to innovation and research means clients get access to the best investment ideas. We have one of the industry’s largest investment strategy teams, with disciplines that…
Added 5 hours ago
Lead, Corporate Accountant
Venterra Realty
Richmond Hill, ON
Full-time
The role will report to the Senior Manager, Accounting who will challenge the candidate to take on increasing levels of responsibility and drive innovation. As a part of the Accounting…
Added 5 hours ago
Manager, Guest Profile Enablement
Four Seasons Hotels and Resorts
Toronto, ON · Four Seasons Corporate Headquarters Toronto
Full-time
…programming is the company’s commitment to supporting cancer research, and the advancement of diversity, inclusion, equality and belonging at Four Seasons corporate offices and properties…
Added 5 hours ago
Surgical Systems Analyst
Sanya’k̓ula
Vancouver, BC
Full-time
…inherent in all aspects of this position. Reporting to the Program Manager, BC Children’s Hospital (BCCH) Surgical Services, the Systems Analyst, Operating Room Scheduling & Operating…
Added 5 hours ago
Lead, Corporate Accountant
Venterra Realty
Richmond Hill, ON
Full-time
The role will report to the Senior Manager, Accounting who will challenge the candidate to take on increasing levels of responsibility and drive innovation. As a part of the Accounting…
Added 5 hours ago
Staff Technical Product Manager
Robots & Pencils
Canada
Full-time
We're looking for a Staff Product Manager to define product strategy and lead delivery across major client engagements. This role is ideal for a seasoned product leader who can own the full…
Added 5 hours ago
Manager, Homestay Program, UCalgary Continuing Education
University of Calgary
Calgary, AB
Full-time
Reporting to the Manager, Customer Service and Operations, the Manager, Homestay Program works closely with the Manager, Group Programs and collaboratively with ELP staff in a…
Added 5 hours ago
Senior Media Technician Events -Information Technologies
University of Calgary
Calgary, AB
Full-time
The technology strategy at the University of Calgary recognizes the dual responsibility of technology within the academy. It must meet the expectation that technology is available,…
Added 5 hours ago
Website Manager
OpTalent | Canada | Recruitment
Toronto, ON · Etobicoke, ON
$100,000 to $130,000 CAD / year
Full-time
Leading the SEO/GEO/AEO strategy is a critical part of this role. The Digital Experience Manager will be responsible for building and managing the company’s organic web presence in…

AstraZeneca

Manager, Regulatory Affairs

Mississauga, ON, Canada
Canada - Mississauga, Canada

Job type: Full-time
Apply by: Oct 13, 2026
Experience: Minimum 7 years of experience in Regulatory Affairs (drugs and biologics) within the pharmaceutical industry is required.
Posting language: English
Posted: Sep 29, 2026

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Original job description

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Position Summary

The Regulatory Affairs Manager, Canada, is responsible for the regulatory activities for the assigned product portfolios. Supporting the Associate Director, Country Regulatory Lead, the Regulatory Affairs Manager will lead/contribute to the development and execution of the regulatory strategies. Collaborate with local and global cross-functional teams as a key regulatory business partner to achieve business objectives.

Principal Requirements:

Responsible for managing the regulatory activities related to the assigned product portfolios.
Liaise with Global Regulatory Affairs Teams (GRL, RA CMC team, labelling and Regulatory Operations) on regulatory strategies and submissions.
Prepare regulatory submissions including NDS/SNDS/NC/Level III AN/YBPRs to Health Canada.
Main portfolio contact for regulatory submissions and Health Canada correspondences/clarification requests.
Works collaboratively with local cross-functional and global teams to ensure key regulatory deliverables are achieved in a timely manner.
Ensure timely communications of regulatory updates and risks to relevant stakeholders.
Utilization of Artificial Intelligence (AI) to augment any applicable regulatory projects and activities.
Manage/build working relationship with Health Canada.
Provide oversight of clinical trial related submissions, including CTA, CTA-Amendment and CTA-Notification to Health Canada as needed.
Develop/maintain Regulatory Affairs Standard Operating Procedures (SOPs).
Coordinate with local Quality and Global Regulatory team in support of Drug Establishment License (DEL) maintenance activities.
Performs intelligence monitoring and communication updates to stakeholders.
Conduct timely review of commercial/medical materials.
Contribute and coordinate reviews of Health Canada policies, guidance and regulation consultations.

Qualifications

Minimum 7 years of experience in Regulatory Affairs (drugs and biologics) within the pharmaceutical industry is required.
Must possess a detailed understanding of the Canadian Food & Drug Regulations, relevant guidelines, and policies.
Proven understanding of drug development and commercialization process
Ability to work within cross-functional environment: i.e. with Global Regulatory, local Commercial, Medical Affairs, Market Access, Safety and Quality teams.
Demonstrated ability to develop regulatory strategies aligned with commercial objectives
Understanding of AI tools/utilization within regulatory activities.
Experience with CTD format
Excellent communication and negotiation skills
Good influencing and relationship leadership skills
Excellent project management skills
Outstanding attention to detail and interpersonal and priority leadership skills
Capacity to perform effectively in a flexible environment to meet all requirements and business requirements

Education

We prefer candidates with an advanced degree (MSc. or PhD.) or equivalent experience. At minimum, a B.Sc. in a life science subject area (biology, chemistry, etc.) and a post-graduate diploma or certification related to Regulatory Affairs is needed.

At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

⠀

Annual base salary for this position ranges from 107,196.80 to 140,695.80.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.

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More about this job

Responsibilities

The Regulatory Affairs Manager is responsible for managing regulatory activities for assigned product portfolios and preparing submissions for Health Canada. They collaborate with cross-functional teams to develop regulatory strategies and ensure compliance with policies and regulations.

Requirements

Candidates must have at least 7 years of experience in Regulatory Affairs within the pharmaceutical industry and a deep understanding of Canadian Food & Drug Regulations. A minimum of a B.Sc. in a life science field combined with a post-graduate diploma or certification in Regulatory Affairs is required.

Skills

Regulatory Affairs
Health Canada submissions
Drug development
Commercialization
Project management
Communication
Negotiation
Influencing
Relationship leadership
Artificial Intelligence
CTD format
Regulatory strategy
Quality assurance
Policy analysis
Clinical trial submissions

Benefits

Flex Benefits
Retirement Savings Program
Paid vacation
Personal Days
Variable Pay Bonus
Short Term Incentive
Equity-based long-term incentive program

Visa sponsorship

Not detected in the job text

Keywords

Regulatory Affairs
Health Canada
Pharmaceutical
Biologics
Drug Establishment License
SOPs
CTD
Artificial Intelligence
Clinical Trials
Compliance
Regulatory Strategy
Commercialization
Medical Affairs
Market Access
Quality Assurance
Submission Management
Life Sciences
Biology
Chemistry
Risk Management
Stakeholder Management
Project Management
Regulatory Operations
Labelling
CMC

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