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Added 13 mins ago
Supply Chain and Planning Manager
Schneider Electric
AB · Edmonton, AB
$114,750 to $162,000 CAD / year
Full-time
This role offers the opportunity to lead the end-to-end supply chain function of a growing manufacturing facility serving Western Canada. Operating in a highly customized Engineer-to-Order…
Added 13 mins ago
Thanks for visiting our Job Board. Please review our open positions and apply to the positions that match your qualifications.
Evertz
Burlington, ON
Full-time
Lead and support customer proof-of-concepts, demonstrations, and technical evaluations - turning what customers need into working configurations.
Added 13 mins ago
Software Developer I
Walmart Canada
Mississauga, ON
Full-time
Actively participate in development scrum meetings and design sessions.
Added 13 mins ago
Station Manager, Construction Technical Office
Ontario Transit Group - Ontario Line - Southern Civil, Stations & Tunnel
Toronto, ON
Full-time
Added 13 mins ago
Murex Integration Delivery Lead
Accenture
Toronto, ON · Montreal, QC
Full-time
You may operate as a Murex Integration Delivery Lead for defined programs or workstreams. You bring credibility with clients, platform vendors, and internal leadership, and you are…
Added 13 mins ago
Principal, Infrastructure Architecture
RBC
Toronto, ON · Mississauga, ON
Full-time
As a Principal, Infrastructure Architecture, you will partner with IT, Operations and business stakeholders to lead development of infrastructure architecture, particularly for high…
Added 13 mins ago
Associate Director, Capital Planning & Reporting
RBC
Toronto, ON
Full-time
Lead development and execution of RBC's Capital Plan and Strategic Outlook; communicate capital assumptions, constraints, and implications across the organization
Added 13 mins ago
Senior Red Team Operator, Adversary Emulation (Global Security)
RBC
Toronto, ON · Ottawa, ON · Calgary, AB
Full-time
Lead projects end-to-end from scoping and proposal writing, through execution, reporting, and stakeholder debriefs.
Added 13 mins ago
Senior Manager Process Re-Engineering
RBC
Toronto, ON
Full-time
Lead the identification and prioritization of re-engineering, automation, and AI transformation opportunities aligned to TEO/OPE strategic priorities and business outcomes and validate…
Added 13 mins ago
Bus Dev Dir (MP Can)
ManpowerGroup
Mississauga, ON
The Business Development Director (BDD) is responsible for selling large scale, comprehensive ManpowerGroup services to clients, primarily focused on new business development. The BDD will…
Added 13 mins ago
Bus Dev Dir (MP Can)
Manpower
Mississauga, ON
The Business Development Director (BDD) is responsible for selling large scale, comprehensive ManpowerGroup services to clients, primarily focused on new business development. The BDD will…
Added 13 mins ago
Stakeholder Engagement Coordinator
Acciona
ON · CAN - Eglinton Crosstown West
Full-time
ACCIONA is a global company, leading in the development of regenerative infrastructure that creates a positive impact on society. Our workforce consists of more than 65,000 professionals,…
Added 13 mins ago
Lead Civil Engineer - Transportation
GHD Group Pty Ltd
Vancouver, BC
We’re looking for a Lead Civil Engineer - Transportation to join our growing Canadian Operations. This position will be based in our Vancouver BC, Edmonton AB, or Calgary AB office. The…
Added 13 mins ago
Maintenance Team Lead
Aspire Bakeries
Ancaster, ON
Growth & Development – Opportunities to build skills, grow your career, and develop expertise through Aspire Bakeries’ learning and development programs.
Added 13 mins ago
Lead Harness Engineer
Government of Alberta
AB
Lead AI development team, guiding teams to deliver AI digital solutions using agile and human-centered design.
Added 13 mins ago
Sales Excellence Manager, North America
Nutreco
Guelph, ON
Full-time
Own your direction, Own your development and Own your path.
Added 13 mins ago
Food Services Manager
Chartwell
Markham, ON
Full-time
…for seniors? As a Food Service Manager at Chartwell, you will lead a dedicated team to deliver high-quality meals and outstanding service. In this role, you’ll be responsible for overseeing…
Added 13 mins ago
Stage Experience Lead
Sephora
Winnipeg, MB
$20.8 to $24.45 CAD / hour
The Stage Experience Lead will be assigned to oversee all sales floor departments within a specific Sephora location. This can include Beauty, Skincare, Fragrance & Haircare or a…
Added 13 mins ago
Senior Manager, Financial Reporting & Insights
BDO
Winnipeg, MB
Full-time
Lead and oversee financial reporting engagements, ensuring timely, accurate, and high-quality deliverables.
Added 13 mins ago
Manager, Organizational Development & Engagement
Volkswagen AG
Ajax, ON
Lead the development, implementation, and continuous improvement of organizational development initiatives, including performance management, succession planning, and talent management…
Added 27 mins ago
Sales Consultant
Sysco
Regina, SK · Sysco Regina
Full-time
Added 27 mins ago
Staff Software Engineer, Data
Solink
Remote, Canada
$138,445 to $173,056 CAD / year
Full-time · Remote
Own the Full Stack: Contribute to both backend and frontend development using Node.js, React, and Serverless frameworks, delivering performant, reliable features used by thousands of…
Added 27 mins ago
Senior Manager, Business Systems
Docker
Remote, Canada
Full-time · Remote
We're looking for a Senior Manager, Business Systems to lead our Salesforce development and administration team and drive the architecture, roadmap, and day-to-day operational health of our…
Added 42 mins ago
Actuarial Manager, Large Accounts Pricing
Aviva Canada
Toronto, ON
Full-time
While the role will not officially have direct reports, you will have accountability for the overall performance and development of actuarial analysts and to foster a positive and dynamic…
Added 42 mins ago
Actuarial Manager, Large Accounts Pricing
Aviva Canada
Markham, ON
Full-time
While the role will not officially have direct reports, you will have accountability for the overall performance and development of actuarial analysts and to foster a positive and dynamic…

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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