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Added 9 mins ago
Sales Manager
HSC Holdings Inc
Oakville, ON
$150,000 to $200,000 CAD / year
Full-time
Our Mercedes-Benz Oakville dealership is looking for a New Vehicle Sales Manager to join our amazing team!
Added 9 mins ago
Lease Portfolio Manager
HSC Holdings Inc
Markham, ON
Full-time
Due to our continued growth, our Volkswagen Unionville dealership is looking for a Lease Portfolio Manager to join our amazing team!
Added 9 mins ago
Event and Fundraising Specialist
Halton Women s Place
Burlington, ON
$55,000 to $61,000 CAD / year
Temporary
Reports to: Manager, Community Engagement and Events
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Crisis Intervention Counsellor - BN2
Halton Women s Place
Burlington, ON
$25.94 to $28.49 CAD / hour
Part-time
Halton Women’s Place is the only Safe Shelter program in the Halton Region. We provide a safe haven, information, education, and counselling, to support women and children to live a life…
Added 9 mins ago
Crisis Intervention Counsellor - Burlington Weekend Overnights
Halton Women s Place
Burlington, ON
$26.94 to $28.49 CAD / hour
Part-time
Halton Women’s Place is the only Safe Shelter program in the Halton Region. We provide a safe haven, information, education, and counselling, to support women and children to live a life…
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Crisis Intervention Counsellor - PTN2 Milton
Halton Women s Place
Milton, ON
$26.94 to $28.49 CAD / hour
Part-time
Halton Women’s Place is the only Safe Shelter program in the Halton Region. We provide a safe haven, information, education, and counselling, to support women and children to live a life…
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Seasonal Sales Associate (Devonshire Mall)
Knix
Windsor, ON
$17.9 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
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Seasonal Sales Associate (Mission)
Knix
Calgary, AB
$19.7 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
Added 9 mins ago
Seasonal Sales Associate (West Edmonton Mall)
Knix
AB
$19.7 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
Added 9 mins ago
Seasonal Sales Associate (Market Mall)
Knix
Calgary, AB
$19.7 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
Added 9 mins ago
Seasonal Sales Associate (Square One)
Knix
Mississauga, ON
$19.7 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
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Seasonal Sales Associate (MacArthur Glen)
Knix
Richmond, BC
$19.7 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
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Seasonal Sales Associate (Rideau)
Knix
Ottawa, ON
$19 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
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Seasonal Sales Associate (Markville Mall)
Knix
Markham, ON
$19.7 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
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Seasonal Sales Associate (West 4th)
Knix
Vancouver, BC
$19.7 CAD / hour
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Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
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Seasonal Sales Associate (Halifax)
Knix
Halifax, NS
$17.9 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
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Seasonal Sales Associate (Guildford)
Knix
Surrey, BC
$19.7 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
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Seasonal Sales Associate (Robson)
Knix
Vancouver, BC
$19.7 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
Added 9 mins ago
Seasonal Sales Associate (Southgate)
Knix
AB
$19.7 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
Added 9 mins ago
Seasonal Sales Associate (Sherway Gardens)
Knix
Toronto, ON
$19.7 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
Added 9 mins ago
Seasonal Sales Associate (Chinook)
Knix
Calgary, AB
$19.7 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
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Seasonal Sales Associate (Don Mills)
Knix
Toronto, ON
$19.7 CAD / hour
Part-time · Contract · Temporary
Product Discounts - Generous Discounts on your favourite Knix products and Gratis Program
Added 9 mins ago
Business Development Manager
Fire safety and protection LLC
Ottawa, ON
$75,000 to $95,000 CAD / year
Full-time
The Business Development Manager is responsible for driving revenue growth through proactive customer acquisition, strategic partnership development, and coordination of marketing…
Added 9 mins ago
Retail Associate 1
Midwest co-operative services
Mount Forest, ON
$17.95 to $19.5 CAD / hour
Part-time
…Retail Associate 1. Under the direction of the Retail Location Manager, the Retail Associate - 1 promotes good customer service and support in MCS retail stores and garden centres. This…
Added 9 mins ago
Housing Navigator
Blue Door Support Services
East Gwillimbury, ON
Full-time
Reporting to the Program Manager, the Housing Navigator is responsible for the successful daily operation of an emergency housing program. In accordance with agency policies and procedures,…

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.

Apply About employer

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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