Manager, Regulatory Affairs
Skills
About the role
This is a Regulatory Affairs Manager role at Alexion Pharmaceuticals (an AstraZeneca Rare Disease company), covering the regulatory activities for assigned product portfolios in Canada, based in Mississauga. It suits an experienced regulatory affairs professional in pharmaceuticals who can work at least three days a week from the office while supporting the Associate Director, Country Regulatory Lead. The role covers regulatory strategy, submissions to Health Canada, and cross-functional collaboration with local and global teams.
What you’ll do
- Manage regulatory activities for assigned product portfolios
- Liaise with Global Regulatory Affairs teams on strategies and submissions
- Prepare regulatory submissions including NDS/SNDS/NC/Level III AN/YBPRs to Health Canada
- Act as main portfolio contact for Health Canada correspondence and clarification requests
- Provide oversight of clinical trial-related submissions including CTA, CTA-Amendment and CTA-Notification
- Develop and maintain Regulatory Affairs SOPs
- Coordinate with Quality and global teams on Drug Establishment License maintenance
- Review commercial and medical materials for compliance
What they’re looking for
- Minimum 5 years of experience in Regulatory Affairs (drugs and biologics) in the pharmaceutical industry
- Detailed understanding of the Canadian Food & Drug Regulations, guidelines and policies
- Proven understanding of the drug development and commercialization process
- Ability to work across cross-functional teams including Global Regulatory, Commercial, Medical Affairs, Market Access, Safety and Quality
- Experience with CTD format
- Excellent communication and negotiation skills
- Excellent project management skills
Nice to have
- Advanced degree (MSc or PhD)
- Understanding of AI tools and their use within regulatory activities
What’s on offer
- Annual base salary ranging from CAD 107,196.80 to CAD 140,695.80
- Variable pay bonus/short-term incentive and equity-based long-term incentive program eligibility
- Flex Benefits & Retirement Savings Program
- 4 weeks' paid vacation and annual personal days
- In-office work averaging a minimum of three days per week
Questions about this role
Is this role remote?
No, it requires an average minimum of three days per week in the office.
How much does it pay?
The base salary ranges from CAD 107,196.80 to CAD 140,695.80.
How many years of experience do I need?
A minimum of 5 years in Regulatory Affairs (drugs and biologics).
What education is preferred?
An advanced degree (MSc or PhD) is preferred, with a minimum of a B.Sc. in a life science field plus a regulatory affairs certification required.
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