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Added 20 mins ago
Product Manager, Business Transformation
FirstService Residential Canada
Mississauga, ON
Full-time
Our dedication to associate satisfaction and growth is recognized by our Great Place to Work certification, exemplifying our commitment to fostering a positive and inclusive workplace…
Added 20 mins ago
Graduate Administrator
Carleton University
Ottawa, ON
Other
Under minimal supervision of the Departmental Administrator, the Graduate Administrator acts as Assistant to the Associate Chair, Graduate Studies. In this capacity, the Graduate…
Added 20 mins ago
Product Manager, Business Transformation
FirstService Residential Canada
Toronto, ON
Full-time
Our dedication to associate satisfaction and growth is recognized by our Great Place to Work certification, exemplifying our commitment to fostering a positive and inclusive workplace…
Added 20 mins ago
Senior Analyst, Events Operations
Walmart Canada
Mississauga, ON
Full-time
…Canada events and business initiatives. Reporting to the Sr. Manager, Event Operations, this role provides operational, financial, sourcing and project support across the event lifecycle,…
Added 20 mins ago
Cashier
Walmart Canada
Mississauga, ON
Contract
Refers appropriate service and transactional items to a Customer Service Manager as required.
Added 36 mins ago
(CAN) Manager, Facility Services
Walmart Canada
Winnipeg, MB
Full-time
Added 36 mins ago
(CAN) Associé, produits consommables
Walmart Canada
Lac-Mégantic, QC
Full-time
Position Summary...Working as a Consumables Associate at Walmart Canada is a great way to develop your skills in the retail industry. The Consumables Associate is a customer service…
Added 36 mins ago
(CAN) Front End Checkout Team Associate
Walmart Canada
Peace River, AB
Full-time
Refers appropriate service and transactional items to a Customer Service Manager or Front End Team Lead.
Added 36 mins ago
(CAN) Caissier
Walmart Canada
Lac-Mégantic, QC
Full-time
Refers appropriate service and transactional items to a Customer Service Manager as required.
Added 36 mins ago
(CAN) Asset Protection Associate
Walmart Canada
Wasaga Beach, ON
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Position Summary...The Asset Protection Associate plays a key role in creating and maintaining a safe, secure, and professional store environment for customers, associates, visitors, and…
Added 36 mins ago
(CAN) Consumables Associate
Walmart Canada
Peace River, AB
Full-time
Position Summary...Working as a Consumables Associate at Walmart Canada is a great way to develop your skills in the retail industry. The Consumables Associate is a customer service…
Added 36 mins ago
Full Time (CAN) Customer Service Manager
Walmart Canada
Charlottetown, PE
$15 CAD / hour
Full-time
Position Summary...Working as a Customer Service Manager at Walmart Canada is a great opportunity to build strong leadership and operational skills in a fast paced retail environment. In…
Added 36 mins ago
(CAN) Day Remodel Associate Temporary
Walmart Canada
Thunder Bay, ON
Full-time
Position Summary...A day remodel associate works with the Remodel Lead and Day Remodel Manager to establish standards in newly renovated departments. They complete modulars, assist…
Added 36 mins ago
Part Time Sales Associate - Dartmouth, NS
Match Retail
Dartmouth, NS
Part-time
As a Sales Associate, you will be the face of our brand, working independently at a kiosk within a retail location. You will engage with customers, provide personalized product…
Added 36 mins ago
(CAN) Over-the-Counter Associate
Walmart Canada
Camrose, AB
Full-time
Position Summary...A Over-the-Counter Associate assists customers, properly zones his/her assigned area, performs tasks delegated by the OTC Department Manager or Pharmacy Manager and…
Added 36 mins ago
Pharmacy Intern
Walmart Canada
Saskatoon, SK
Full-time
In collaboration with the designated pharmacy manager and his/her preceptor, the intern adheres to the drug distribution protocols of the pharmacy to ensure safety, accuracy and quality of…
Added 36 mins ago
(CAN) Fashion Department Manager
Walmart Canada
Kamloops, BC
Full-time
Position Summary...The Fashion Department Manager plays a key leadership role in bringing the fashion departments to life each day. By leading and supporting fashion associates, this role…
Added 36 mins ago
Sales Associate
Staples Retail
Brampton, ON
Part-time
Calmly de-escalate and assist in complex customer situations to ensure their concerns are addressed effectively or refer to a manager/supervisor.
Added 50 mins ago
Overnight Remodel Associate
Walmart Canada
AB · Edmonton, AB
Contract
Position Summary...An overnight remodel associate works with the Overnight Remodel Manager to establish standards in newly renovated departments. They complete modulars, ensure high-ticket…
Added 50 mins ago
(CAN) Directs Store Delivery Associate
Walmart Canada
AB · Edmonton, AB
Full-time
Works closely with the Operations Manager and Office Support Associate to identify and resolve receiving issues or discrepancies efficiently.
Added 50 mins ago
Overnight Remodel Associate
Walmart Canada
AB · Edmonton, AB
Contract
Position Summary...An overnight remodel associate works with the Overnight Remodel Manager to establish standards in newly renovated departments. They complete modulars, ensure high-ticket…
Added 50 mins ago
(CAN) Consumables Associate
Walmart Canada
Cobourg, ON
Full-time
Position Summary...Working as a Consumables Associate at Walmart Canada is a great way to develop your skills in the retail industry. The Consumables Associate is a customer service…
Added 50 mins ago
(CAN) Pharmacy Assistant
Walmart Canada
Timmins, ON
Full-time
Assisting with OTC Operations and ordering, stocking, cashier duties as assigned by OTC Manager and/or Pharmacist.
Added 50 mins ago
(CAN) Self Checkout Attendant
Walmart Canada
Terrace, BC
Full-time
…and escalate cash or technical issues to the Customer Service…
Added 50 mins ago
(CAN) Cashier
Walmart Canada
London, ON
Full-time
Refers appropriate service and transactional items to a Customer Service Manager as required.

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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