A
s Senior Director for Regulatory Affairs, you will be responsible for regulatory clinical, non-clinical, and procedural strategies and activities for ALK’s products and projects. You will be part of Global Regulatory Affairs, Safety & Pharmacovigilance (GRASP) where you will lead one of three key functions and serve as part of the leadership team, reporting to the Senior Vice President, GRASP.
You will play a pivotal role in shaping and executing our global regulatory strategy across multiple regions. This strategic position involves overseeing regulatory activities across diverse international markets through a number of talented global teams and driving cross-functional collaboration across multicultural settings. As a trusted partner within the organisation, your function will contribute to ALK’s ongoing success in building a pipeline and delivering transformative allergy treatments with your curiosity and innovative mindset.

Your primary tasks will be:

• Develop and oversee global regulatory strategies that align with business objectives and ensure successful regulatory approvals worldwide.
• Develop, maintain and oversee regulatory IT systems and projects.
• Provide strategic leadership and empower teams of regulatory leaders and professionals across Europe, China, and the US, fostering excellence, engagement, and continuous development.
• Ensure regulatory submissions meet local and international compliance standards, including EMA, FDA, and other authorities.
• Drive partnerships with R&D, Commercial Operations, and other key functions to ensure seamless regulatory integration with internal and external stakeholders.
• Identify, evaluate, and proactively mitigate regulatory risks, ensuring smooth product development and regulatory approvals.
• Monitor global regulatory changes and trends, adapting strategy to ensure alignment with evolving standards.
• Continuously improve workflows and processes to enhance efficiency and elevate the regulatory function globally.

• Develop and oversee global regulatory strategies that align with business objectives and ensure successful regulatory approvals worldwide.
• Develop, maintain and oversee regulatory IT systems and projects.
• Provide strategic leadership and empower teams of regulatory leaders and professionals across Europe, China, and the US, fostering excellence, engagement, and continuous development.
• Ensure regulatory submissions meet local and international compliance standards, including EMA, FDA, and other authorities.
• Drive partnerships with R&D, Commercial Operations, and other key functions to ensure seamless regulatory integration with internal and external stakeholders.
• Identify, evaluate, and proactively mitigate regulatory risks, ensuring smooth product development and regulatory approvals.
• Monitor global regulatory changes and trends, adapting strategy to ensure alignment with evolving standards.
• Continuously improve workflows and processes to enhance efficiency and elevate the regulatory function globally