Manager, Regulatory Affairs

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 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

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. 

#LI-Hybrid

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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.