Manager, Regulatory Affairs

AstraZeneca • Mississauga, ON

1d • CA$107,197 - CA$140,696 • Hybrid

About The Position

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.

Requirements

• Minimum 5 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

Nice To Haves

• We prefer candidates with an advanced degree (MSc. or PhD.) or equivalent experience.

Responsibilities

• 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.

Benefits

• Annual base salary for this position ranges from 107,196.80 to 140,695.80.
• Annual Variable Pay Bonus/Short Term Incentive opportunity
• Eligibility to participate in our equity-based long-term incentive program (if applicable to role).
• Competitive Flex Benefits & Retirement Savings Program
• 4 weeks’ paid vacation
• annual Personal Days.
• Contract Benefits Program

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree