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Added 3 mins ago
C
Manager, AI Platforms (Permanent)
CoreFactor
Toronto, ON
- Full-time
This position is hybrid and will require the successful incumbent to be in the office two (2) days per week.
Added 3 mins ago
SQ
District Manager
Sunlife Québec
Quebec, QC
- Full-time
The primary purpose of the District Manager (DM) is to lead the growth and productivity of the District. This is done by recruiting top talent, coaching and developing advisors and the…
Added 3 mins ago
SQ
District Manager
Sunlife Québec
Levis, QC
- Full-time
The primary purpose of the District Manager (DM) is to lead the growth and productivity of the District. This is done by recruiting top talent, coaching and developing advisors and the…
Added 3 mins ago
H
Global Mining Practice Business Development Leader
HDR
Kingston, ON
- Full-time
Support the Mining Practice Lead in development of growth priorities and investment decisions for the Industrial Resources Business Group leadership and regional operations.
Added 3 mins ago
LC
Supervisor, Production
Loblaw Companies Limited
Mississauga, ON
- Full-time
The Supervisor Production will assist the Pharmacy Operations Management Team in overseeing the day-to-day workflow process of their team within Operations and to ensure optimal customer…
Added 3 mins ago
I
Customer Experience Leader (Contract 18+ Months)
Indigo
London, ON
- $18.6 to $23.25 CAD / hour
- Contract
The Customer Experience Leader is the execution lead of all customer programs and results. This position role models and coaches to create a high-performance, customer-focused environment…
Added 3 mins ago
Y
Senior Project Manager
YORK1
Concord, ON
- Full-time
Provide expertise and guidance on bidding tenders, RFP's, RFQ's and lead the operations team during project execution
Added 3 mins ago
C
Ops Mgmt Manager
CBRE
Toronto, ON
- Full-time
Ensure business operations are implemented based on established procedures.
Added 3 mins ago
LM
Manager, Workplace Operations & Executive Support - Canada
Liberty Mutual Canada
Toronto, ON
- Full-time
Lead day-to-day workplace operations across Liberty Mutual Canada offices, including reception, catering, mail and delivery services, meeting-room readiness, office access and general…
Added 3 mins ago
ML
Sourcing Buyer
Maple Leaf Foods Inc
Mississauga, ON
- $71,000 to $103,000 CAD / year
- Full-time
The Sourcing Buyer will work closely with Procurement operations, the leadership team, and key stakeholders on competitive cost sourcing initiatives of assigned spend categories. This role…
Added 3 mins ago
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Assistant Production Manager – Food Manufacturing
Aplin
AB · Edmonton, AB
- Full-time
Lead with confidence. Develop people. Drive production performance.
Added 3 mins ago
IF
Director - Governance & Client Account Management
International Financial Data Services (IFDS)
Toronto, ON
- Full-time
Lead the identification and documentation of risks and controls across changes and initiatives (projects, service requests, incidents and adhoc initiatives such as proactive testing of…
Added 4 mins ago
LC
Senior Strategic Sourcing Specialist- Packaging
Lactalis Canada
Toronto, ON · Etobicoke, ON
- Full-time
…Additionally, the Senior Buyer will collaborate with Plant Operations, Packaging Development, Marketing, Finance, Supply Chain and Global Procurement Team to align duties with the company's…
Added 4 mins ago
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Manager, Growth Engineering
TransAlta
Calgary, AB
- Full-time
…Reporting to the Director, Development, you will establish and lead an integrated Growth Engineering function responsible for providing the technical foundation for the evaluation and…
Added 4 mins ago
E
Technicien.ne comptable & administratif·ve │ Accounting & Administrative Technician
Evvo
Remote, Canada
- Full-time
- Remote
…day-to-day accounting (payables, receivables, payroll) and the operations of our Montreal office. If you're detail-oriented,…
Added 4 mins ago
CI
Manager, AI Platforms (Permanent)
CoreFactor Inc.
Toronto, ON · Downtown Toronto (Ryerson), Ontario
- Full-time
This position is hybrid and will require the successful incumbent to be in the office two (2) days per week.
Added 19 mins ago
UO
Director Co-op & Career Development, UC Clermont College
University of Cincinnati
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- Full-time
…experiential learning, student success, and post-graduate outcomes. Lead the development and continuous improvement of Career Services programs, services, communications, systems, and…
Added 19 mins ago
H
Global Mining Practice Business Development Leader
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Saskatoon, SK
- Full-time
Support the Mining Practice Lead in development of growth priorities and investment decisions for the Industrial Resources Business Group leadership and regional operations.
Added 19 mins ago
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Accounting Manager
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Halifax, NS
- Full-time
…operating entities. Reporting to the Director of Finance, you'll lead the day-to-day accounting function, oversee a talented accounting team, and play a critical role in delivering timely…
Added 19 mins ago
S
Facilities Manager
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Vancouver, BC
- Full-time
…in Asia, Europe, and the Americas. Solidigm will continue to lead the world in innovating new Memory technologies with aspirations to be the #1 NAND memory company in the world. At…
Added 34 mins ago
C
Associate, Private Fund Solutions
Clarity
Vancouver, BC
- $200,000 to $250,000 CAD / year
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A front-office origination role covering institutional clients.
Added 34 mins ago
CB
National Account Manager
Canadian Bar Association
Ottawa, ON
- Full-time
…portfolio of national accounts, serving as the primary relationship lead for multi-jurisdictional organizations and driving their retention, renewal, and growth. The ideal candidate is a…
Added 34 mins ago
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US Corporates - Senior Credit Analyst, Utilities & Midstream - Toronto
Fitch Ratings
Toronto, ON
- Full-time
…Group, a global leader in financial information services with operations in more than 30 countries, which also includes Fitch Solutions. With dual headquarters in London and New York, Fitch…
Added 34 mins ago
LC
Associate, Warehouse
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Calgary, AB
- Full-time
…and quality assurance tasks, ensuring efficient and routine…
Added 35 mins ago
WC
Senior Advisor to the CEO
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Winnipeg, MB
- Full-time
…the Executive Administrative staff while overseeing the daily operations of the President and CEO's (CEO) Office. Working in close partnership with executive leadership, this role…

AstraZeneca

Manager, Regulatory Affairs

Mississauga, ON, Canada
Canada - Mississauga, Canada

Full-time

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Job details

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

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 and a post-graduate diploma or certification in Regulatory Affairs is required.

Skills

Regulatory Affairs
Drug Development
Commercialization
Health Canada Regulations
Regulatory Strategy
Project Management
Communication
Negotiation
Influencing
Relationship Leadership
Artificial Intelligence
CTD Format
Quality Assurance
Clinical Trial Submissions
Policy Analysis

Benefits

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

Visa sponsorship

Not detected in the job text

Keywords

Regulatory Affairs
Pharmaceutical Industry
Health Canada
NDS
SNDS
CTA
Drug Establishment License
Artificial Intelligence
CTD
Biologics
Compliance
SOPs
Commercialization
Medical Affairs
Market Access
Quality Assurance
Regulatory Strategy
Project Management
Life Sciences
Rare Disease Research

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