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Caissier/caissière temps partiel jour
Loblaw Companies Limited
Montreal, QC
- Part-time
Support in the delivery of company-directed promotions and programs
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Caissier/caissière temps partiel jour
Loblaw Companies Limited
Montreal, QC
- Part-time
…invisible, temporary or permanent) can be made at any stage of application and employment. We encourage candidates to make their accommodation needs known so that we can provide equitable…
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HBA Clerk Part Time Day
Loblaw Companies Limited
Ottawa, ON
- Part-time
…invisible, temporary or permanent) can be made at any stage of application and employment. We encourage candidates to make their accommodation needs known so that we can provide equitable…
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Épicerie Commis temps partiel nuit
Loblaw Companies Limited
Richelieu, QC
- Part-time
…invisible, temporary or permanent) can be made at any stage of application and employment. We encourage candidates to make their accommodation needs known so that we can provide equitable…
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Bakery InStore Clerk Part Time Day
Loblaw Companies Limited
Whitehorse, YT
- Part-time
…invisible, temporary or permanent) can be made at any stage of application and employment. We encourage candidates to make their accommodation needs known so that we can provide equitable…
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Bakery InStore Clerk Part Time Day
Loblaw Companies Limited
Winnipeg, MB
- Part-time
…invisible, temporary or permanent) can be made at any stage of application and employment. We encourage candidates to make their accommodation needs known so that we can provide equitable…
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Grocery Clerk Part Time Day Greenlight Requisition
Loblaw Companies Limited
Sechelt, BC
- Part-time
…invisible, temporary or permanent) can be made at any stage of application and employment. We encourage candidates to make their accommodation needs known so that we can provide equitable…
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Cashier Part Time Day
Loblaw Companies Limited
Bay Roberts, NL
- Part-time
Support in the delivery of company-directed promotions and programs
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Repas sur le pouce Commis temps partiel jour Embauche feu vert
Loblaw Companies Limited
Mont-Royal, QC
- Part-time
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Commis du bar à café – syndiqué temps partiel jour
Loblaw Companies Limited
Longueuil, QC
- Part-time
…invisible, temporary or permanent) can be made at any stage of application and employment. We encourage candidates to make their accommodation needs known so that we can provide equitable…
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Cashier Part Time Day
Loblaw Companies Limited
Whitehorse, YT
- Part-time
Support in the delivery of company-directed promotions and programs
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Courtesy Clerk Part Time Day
Loblaw Companies Limited
Whitehorse, YT
- Part-time
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SAP Operations Clerk Part Time Day
Loblaw Companies Limited
Calgary, AB
- Part-time
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Trainee, Franchise Part Time Day Greenlight Requisition
Loblaw Companies Limited
Surrey, BC
- Part-time
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Cashier Part Time Day
Loblaw Companies Limited
Bonnyville, AB
- Part-time
Support in the delivery of company-directed promotions and programs
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Analyste de test technique principal·e I Technical Test Lead
2K Vegas
Montreal, QC
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Pharmacist, Hourly Part Time Flexible Shifts
Shoppers Drug Mart
Mississauga, ON
- Part-time
Proven ability to drive and build the business, lead by example and support enterprise programs
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Beauty Specialist, Hourly Part Time Day
Shoppers Drug Mart
Toronto, ON
- Part-time
Ability to conduct sit down makeup and skincare consultations and demonstrate application
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Apparel Department Manager Part Time Day
Loblaw Companies Limited
Embrun, ON
- Part-time
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Cashier Part Time Day
Loblaw Companies Limited
Penticton, BC
- Part-time
Support in the delivery of company-directed promotions and programs
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Home Clerk Part Time Day
Loblaw Companies Limited
North Vancouver, BC
- Part-time
…invisible, temporary or permanent) can be made at any stage of application and employment. We encourage candidates to make their accommodation needs known so that we can provide equitable…
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Caissier/caissière temps partiel jour
Loblaw Companies Limited
Saguenay, QC
- Part-time
…invisible, temporary or permanent) can be made at any stage of application and employment. We encourage candidates to make their accommodation needs known so that we can provide equitable…
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Personal Shopper Part Time Day
Loblaw Companies Limited
Edmonton, AB
- Part-time
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HMR Clerk Part Time Day
Loblaw Companies Limited
Fredericton, NB
- Part-time
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Produce Clerk Part Time Evening
Loblaw Companies Limited
Guelph, ON
- Part-time
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Alexion Pharmaceuticals, Inc.

Manager, Regulatory Affairs

Mississauga, ON, 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: Sep 4, 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

Manage regulatory activities for assigned product portfolios, including developing and executing regulatory strategies and preparing drug and clinical trial submissions to Health Canada. Partner with local and global teams, maintain Health Canada relationships, communicate regulatory updates and risks, and support compliance, licensing, and review activities.

Requirements

Requires at least seven years of pharmaceutical regulatory affairs experience with drugs and biologics, detailed knowledge of Canadian regulations and guidance, and experience with drug development, commercialization, and CTD submissions. Requires a life sciences bachelor's degree and a regulatory affairs postgraduate diploma or certification at minimum; an advanced degree or equivalent experience is preferred.

Skills

Regulatory Affairs
Canadian Food and Drug Regulations
Regulatory Strategy
Regulatory Submissions
Health Canada Liaison
Drug Development and Commercialization
Cross-Functional Collaboration
Artificial Intelligence Utilization
Clinical Trial Submissions
Standard Operating Procedures
Regulatory Intelligence Monitoring
Commercial and Medical Materials Review
CTD Format
Project Management
Communication and Negotiation

Benefits

Variable Pay Bonus
Equity-Based Long-Term Incentive Program
Flexible Benefits Program
Retirement Savings Program
Four Weeks' Paid Vacation
Annual Personal Days

Visa sponsorship

Not detected in the job text

Keywords

Regulatory Affairs
Health Canada
Canadian Food and Drug Regulations
Drug and Biologic Products
New Drug Submission
Notifiable Change
Level III Annual Notification
Yearly Biologic Product Report
Clinical Trial Application
Clinical Trial Amendment
Clinical Trial Notification
Common Technical Document
Regulatory Strategy
Regulatory Operations
Chemistry, Manufacturing, and Controls
Product Labelling
Drug Establishment License
Standard Operating Procedures
Regulatory Intelligence
Artificial Intelligence
Drug Development
Commercialization
Cross-Functional Collaboration
Commercial Materials Review
Medical Materials Review
Regulatory Policy Consultation

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