Senior Director, Head of Labeling Regulatory Affairs

When we put unexpected teams in the same room, we fuel bold thinking with the power to encourage 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 Senior Director, Head of Labeling will be responsible for the oversight and management of Alexion’s Global Labeling team.  In this capacity, the successful candidate will be responsible for all aspects of Alexion’s labeling process across the entire portfolio with a goal of achieving the successful registration and lifecycle management of unique and technically sophisticated products within the Rare Disease therapeutic area. 

The scope of activities this position will lead include, but are not limited to:

• Coordinate the development and maintenance of all core labelling documents, including:
  • Company Core Data Sheet (CCDS)
  • US Prescribing Information
  • EU Summary of Product Characteristics (SmPC)
  • Japan Packing Insert
    
• Liaison with country regulatory representatives on anticipated labeling filings
• Manage all timelines associated with label updates across the portfolio
• Ensure the accurate and timely tracking of all labeling submissions and approvals
• Engage in cross functional activities to ensure key partners are infoadvisedlabeling requirements
• Provide mentorship, leadership and oversight to a distributed/global team
• Ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities

Primary Responsibilities:

• Collaborate with Senior Management and Enterprise functions (e.g. Clinical, Commercial, Medical Affairs) to provide global and regional labeling insight and broader drug development expertise
• Oversees all activities associated with implementing labeling strategies and operations for all products in the portfolio and ensuring to overall Enterprise objectives and global regulatory strategies through initial registration and subsequent lifecycle management
• Accountable for the people management of the labeling team and ensuring optimal utilization of staff for assigned products/programs
• Collaborate with Global Regulatory Leads to ensure activities and deliverables completed on time and resourced accurately
• Ensure all communications with health authorities during label negotiations are maintained in a consolidated tracking form and updates to proposed and agreed upon changes are captured and communicated in a timely manner
• Capture global deviations to the CCDS, maintaining an accurate and up-to-date record of current label status by country and reviewing labelling artwork
• Support provision of advice and input from execution and regional strategy teams to internal Governance and advisory bodies
• Proactively track all regulatory requirement updates and trends and ensuring communication to broader Regulatory Affairs organization

Qualifications

• Bachelor’s degree in a scientific or technical subject area with at least 10 years proven experience
• Postgraduate degrees relevant to the role (e.g. MSc, PhD) a plus
• Experience in labeling strategies and operations (e.g. EU, US, International)
• An understanding of regulatory processes, regulations and policy
• Experience providing leading and managing cross-skilled regulatory staff to deliver on business objectives, in mentoring and developing staff
• Ability to manage sophisticated issues and coordinate multiple projects simultaneously in a time-sensitive fashion
• Ability to develop positive relationships and collaborate in a distributed team environment at all levels of the organization
• Highly conversant and knowledgeable of new and emerging regulations and guidance
• Understanding of GxPs at relevant areas and solid understanding of where to seek and how to interpret regulatory information
  

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.

Alexion 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 follow all applicable laws and regulations on inclusivity in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Ready to lead and inspire? Apply now and take the first step towards an exciting career at Alexion, AstraZeneca Rare Disease.

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 authorisation and employment eligibility verification requirements.