Associate Director, Regulatory Labeling Strategy

At Alexion, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

Our dedication to sustainability is also central to our culture and part of what makes Alexion a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

This is what you will do:

The Associate Regulatory Affairs Director, Labeling Regulatory Affairs, plays a pivotal role in shaping and implementing strategic labeling initiatives for the Alexion portfolio, encompassing pharmaceutical development projects, marketed products, and device registrations. This role is critical in ensuring that labeling strategies not only align with global regulatory standards but also provide a competitive advantage. With a proactive and high-impact approach, the Associate Director will deliver strategic regulatory labeling insights, guidance to cross-functional teams, and Core Labeling Content, driving successful outcomes for global programs.

You will be responsible for:

• Regulatory Labeling Strategy: Serve as the Regulatory Labeling Lead for assigned project(s)/product(s). Develop, implement, and maintain global regulatory labeling strategies, implementation plans, and input to risk management plans to support successful registration and lifecycle management with desired labeling.
• Product Label Development: Lead the development of Target Product Labels (TPL), Core Documents such as Company Core Data Sheets (CCDS), US Package Insert (US PI), and European Summary of Product Characteristics (EU SmPC) in alignment with Global Regulatory Strategy.
• Competitor Intelligence: Conduct detailed competitive intelligence labeling analysis for approved and development products to inform and optimize program labeling strategies.
• Collaboration & Communication: Build effective relationships with regulatory project teams and cross-functional teams, including market access, commercial, clinical, safety and compliance colleagues, to align regulatory labeling initiatives with Target Product Profiles. Lead-cross functional teams to obtain desired labels and convincingly present labeling strategies including governance meetings.
• Data-Driven Strategy Adjustment: Continuously assess the impact of emerging data on regulatory Target Product Label within the portfolio, adjusting labeling strategies as necessary.
• Health Authority Interactions: Provide strategic labeling input to interactions with Health Authorities, including submissions and negotiations.
• Compliance & Process Management: Ensure collaborator compliance with relevant labeling processes and contribute to labeling-related SOP development and revision. Contribute to initiatives improving regulatory workflows and approaches.
• Legislative and Regulatory Monitoring: In collaboration with Regulatory Intelligence and Policy colleagues, supervise the external environment for significant legislative/regulatory developments, and update strategic labeling advice for project/product teams accordingly.
• Artwork Development: Collaborate with global regulatory leads in artwork development.
• Audit Representation: Represent Alexion Labeling in audits and inspections.
• Mentorship & Guidance: Mentor and guide team members, supporting skill and capability enhancement.
• Exemplary Leadership: Maintain outstanding behavior, ethics and transparency within the Enterprise, with Health Authorities, and other external partners.

You will need to have:

• Minimum of 7+ years of proven experience, including the development and implementation of at least one successful global regulatory labeling strategy for a commercialized product.
• Preference to experience with orphan drugs.
• Solid understanding of drug development and regulatory intelligence, coupled by excellent scientific and business judgment.
• Ability to manage sophisticated issues and timely coordinate multiple projects simultaneously.
• Ability to build intra- and inter-team relationships and collaborate in a distributed team environment at all levels of the organization, especially Senior Management.
• Ability to understand and bring to bear cross-functional expertise to build and communicate compelling and successful regulatory labeling strategies.
• Strong interpersonal and written/verbal communication skills.
• Proven track record practicing sound judgment in risk assessment.
• Keen understanding of new and emerging regulations and guidance.
• Proficiency in MS Office tools and Veeva-based platforms.

Preferred Qualifications.

Bachelor’s degree (preferably in life sciences) or equivalent level of experience. 

Project Management certificate preferred.

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 10 years
• Top 100 Employers Award
• Canada’s Most Admired Corporate Culture
• Learn more about working with us in Canada
• View our YouTube channel

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.