Senior Director, Global Regulatory Affairs

Are you ready to take on a highly strategic and global leadership role within a growing global pharmaceutical company? Do you have strong regulatory expertise, combined with international experience and a passion for collaboration across cultures and functions? Do you want to contribute to building a strong pipeline of innovative solutions for people with allergy?

The position
As 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.

Your profile
We expect that you have:

• A master’s degree in pharmacy/science, an MD, or a related field (advanced degrees preferred).
• At least 10 years of experience in Regulatory Affairs, with demonstrated experience in managing submissions across EMA, FDA, and other regulatory jurisdictions.
• Strong leadership and mentorship capabilities, with the ability to lead globally and actively engage and empower teams to deliver high-quality results.
• Strong stakeholder management skills.
• Excellent cooperation and communication skills, with the ability to navigate cross-functional and multicultural dynamics effectively.
• A strong ability to think critically and strategically, identifying opportunities and challenges within the regulatory landscape.
• Experience from and thrive in fast-paced, dynamic environments and demonstrate resilience in managing complex priorities and tasks.

As this is a global role, international travel should be expected.

Become a part of ALK
ALK provides a dynamic and accommodating work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organisation, and in the role, you are able to actively influence and challenge the status quo.

Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. We consider our pioneering spirit, coupled with our trustworthiness, our winning formula. ALK is a health focused organisation with our head office located in Hørsholm, Denmark.

Join us at ALK and be a part of a team that values integrity, innovation, and making a difference in the lives of those we serve.

Apply
With our ambitious Allergy+ strategy, ALK is embarking on an exciting growth journey, aiming to double the number of patients we help by 2030. We are expanding our reach, developing new solutions, and optimising our operations to address the increasing global need for allergy care. Joining ALK means contributing directly to this impactful mission and helping millions live healthier lives.

Apply by attaching your CV and a short letter of motivation, no later than 10 September 2025.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Hence, we prefer that you do not add images in your application documents. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

Do you want to learn more about our company, we encourage you to visit us at [xxxxx] For further information regarding the position please contact SVP GRASP Anne Lützhøft Aarbogh at +[xxxxx].

We are looking forward to hearing from you!