ESSENTIAL SKILLS/EXPERIENCE:

• Minimum of 7+ years of relevant 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.
• Strong knowledge of drug development and regulatory intelligence, coupled by excellent scientific and business judgment.

• Ability to manage complex issues and timely coordinate multiple projects simultaneously.

• Ability to build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization, especially Senior Management.

• Ability to understand and leverage 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.

DESIRABLE SKILLS/EXPERIENCE:

• Bachelor’s degree (preferably in life sciences) or equivalent level of experience.
• Project Management certificate preferred.
  At AstraZeneca’s Alexion division, we are driven by a passion for innovation and a commitment to making a difference in the lives of those living with rare diseases. Our unique blend of entrepreneurial spirit and global resources allows us to continuously push boundaries in research and development. Here, you’ll find an energizing culture that fosters collaboration, creativity, and personal growth. We are dedicated to empowering our employees with tailored development programs that align with our mission to improve patient outcomes. Join us in our journey to transform lives through groundbreaking science!
  If you’re ready to be part of a team that is redefining the future of healthcare, we want to hear from you!

INTRODUCTION TO ROLE:

Are you ready to make a significant impact in the world of rare diseases? As the Associate Director of Regulatory Labeling Strategy at Alexion, you will play a crucial role in shaping and executing strategic labeling initiatives for our diverse portfolio. This position is vital in ensuring that our labeling strategies not only meet global regulatory standards but also provide a competitive edge. With a proactive approach, you will deliver strategic regulatory labeling insights and guidance to cross-functional teams, driving successful outcomes for global programs. Join us in this pivotal role and help us lead the way in pharmaceutical development and device registrations!

YOU WILL BE RESPONSIBLE FOR:

• Regulatory Labeling Strategy: Serve as the Regulatory Labeling Lead for assigned projects/products. 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 stakeholder 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, monitor 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 exemplary behavior, ethics, and transparency within the Enterprise, with Health Authorities, and other external stakeholders.