Manager, Regulatory Affairs

AstraZeneca
Mississauga
Workplace: HybridFull time107,196.8 - 140,695.8 annuallyFunction: Quality & Regulatory (Non-Software)Experience: 5+ yearsEducation: mastersSkills: ["Communication","Negotiation","Influencing","Project management","Attention to detail"]

Lead regulatory activities for assigned drug/biologics product portfolios in Canada, supporting regulatory strategy development and execution. Serve as the primary contact for Health Canada submissions and correspondence, coordinating with global and local teams to deliver timely regulatory submissions (including NDS/SNDS/NC and Level III AN/YBPRs) and clinical trial application materials. Monitor and communicate regulatory updates, manage SOPs, oversee key deliverables, and leverage AI tools to augment regulatory work.

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FursaFursa
AstraZeneca
AstraZeneca
6 days ago

Manager, Regulatory Affairs

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Source: Company careers pageValidated by: Fursa AI
Last checked: 7 hours agoStatus: Live

Job Summary

Lead regulatory activities for assigned drug/biologics product portfolios in Canada, supporting regulatory strategy development and execution. Serve as the primary contact for Health Canada submissions and correspondence, coordinating with global and local teams to deliver timely regulatory submissions (including NDS/SNDS/NC and Level III AN/YBPRs) and clinical trial application materials. Monitor and communicate regulatory updates, manage SOPs, oversee key deliverables, and leverage AI tools to augment regulatory work.
Location: Mississauga
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Manage regulatory activities for assigned product portfolios in Canada and lead/contribute to regulatory strategy development and execution.
  • •Coordinate with Global Regulatory Affairs teams (GRL, RA CMC, labelling, and Regulatory Operations) on regulatory strategies and submissions.
  • •Prepare and manage regulatory submissions to Health Canada, including NDS/SNDS/NC and Level III AN/YBPRs, and handle Health Canada clarifications.
  • •Oversee clinical trial related submissions as needed (CTA, CTA-Amendment, CTA-Notification) and ensure timely cross-functional delivery of regulatory deliverables.
  • •Develop/maintain regulatory SOPs, monitor regulatory intelligence, and conduct timely review of commercial/medical materials; support Health Canada policy/guidance consultations.

Pay and Benefits

Salary: 107,196.8 - 140,695.8 annually
Equity and Bonus:Equity
Perks:Paid LeavePersonal DaysRetirement Savings

Key Requirements

  • •Minimum 5 years of Regulatory Affairs experience for drugs and biologics within the pharmaceutical industry.
  • •Detailed knowledge of Canadian Food & Drug Regulations, relevant guidelines, and policies.
  • •Proven understanding of drug development and commercialization, including regulatory strategy aligned with commercial objectives.
  • •Experience preparing regulatory submissions in CTD format (including NDS/SNDS/NC and Level III AN/YBPRs).
  • •Understanding of AI tools/utilization within regulatory activities and ability to collaborate cross-functionally.
Experience:5+ yearsPharmaceutical industryDrugsBiologics
Education:Master's
Skills:CommunicationNegotiationInfluencingProject managementAttention to detail
Tech Stack:CTDAI

Company Brief

AstraZeneca
Global biopharmaceutical company discovering, developing and commercializing prescription medicines across oncology, cardiovascular, renal & metabolism, respiratory, and immunology, focused on innovative therapies and vaccines to improve patient outcomes worldwide.
Industry: Pharmaceuticals
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Cambridge, United Kingdom
Founded: 1999
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