Director, Global Regulatory Affairs

Job title:

Director, Global Regulatory Affairs

Company

ALK-Abelló

Job description

Are you ready to take on a strategic regulatory affairs role within a growing global pharmaceutical company? Do you have regulatory experience with early- and late-stage development projects and managing global regulatory procedures? Are you an inspiring leader who wants to make a difference for people with allergy?The position
Global Regulatory Affairs is a function within the Global Regulatory Affairs, Safety and Pharmacovigilance (GRASP) organisation. You will be responsible for regulatory clinical, non-clinical, and procedural strategies and activities for ALK’s products and projects, and you will lead a team of approximately 10 skilled regulatory professionals. You will report to the Senior Director Global Regulatory Affairs and be part of the Global Regulatory Affairs leadership team.Your primary tasks will be:

• Formulate regulatory clinical, non-clinical, and procedural strategies for ALK’s products and projects, and ensure appropriate regulatory core team representation in development projects.
• Lead and mentor a team of 10 regulatory professionals and promote a positive team culture that encourages collaboration and accountability.
• Drive regulatory submissions and interactions with health authorities together with the team.
• Facilitate cross-functional cooperation and communication across ALK and with external stakeholders to enhance regulatory processes and outcomes, and to ensure alignment on strategic objectives.
• Develop and maintain product labelling in compliance with regulations and contribute to the creation and approval of Printed Packaging Material.
• Monitor and ensure compliance with regulatory standards and internal policies and maintain and update Quality Documents (SOPs and WINs) to reflect current practices.
• Perform regulatory surveillance and analyse regulatory changes and their impact and suggest actions.
• Provide regular updates to senior management on regulatory progress, challenges, and strategic initiatives.
• Prepare reports and presentations that communicate complex regulatory information clearly

Your profile
We expect that you have:

• A master’s degree in pharmacy/science, an MD, or a related field (advanced degrees preferred).
• Experience in Regulatory Affairs, with demonstrated experience in formulating regulatory strategies and managing global submissions (candidates with early-stage development experience preferred).
• Strong leadership and mentorship capabilities.
• Strong stakeholder management skills.
• Strong communication skills with a desire to work cross-functionally and multiculturally.
• A curious and creative mindset and enjoy challenges and a fast-paced, dynamic environment.

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 31 August 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 . For further information regarding the position please contact SVP GRASP Anne Lützhøft Aarbogh at +45 3816 7070.We are looking forward to hearing from you!Send applicationShare on:Region:

• Region Hovedstaden

Job type:PermanentWorking hours:Full-timeWorking days:DayIndustry sector:Regulatory AffairsJob level:DirectorPosition type:ManagerApplication deadline:31/08/2025Location:Hørsholm, DenmarkCompany homepage:Office address:Bøge Allé 1 2970 HørsholmOffice location:ALK-Abelló A/SALK helps people living with allergy. By providing solutions that make life with allergy surprisingly simple we make a difference for many people. We build upon a strong heritage as a pioneer in allergy immunotherapy and we will continue to innovate, develop and market new products and solutions for people with allergy.
ALK is a global company with production sites in Denmark, France, Spain and the United States. We were founded in Copenhagen in 1923. Headquartered in Hørsholm, Denmark, ALK employs around 2,900 people worldwide and is listed on Nasdaq Copenhagen.
We know that our employees are our most valuable asset and we believe they do their very best every day in the pursuit of new and better allergy treatments and solutions for people with allergy around the world. If you like to have influence and make a difference ALK is the right place so come join us on our exciting journey.

Expected salary

Location

Hørsholm, Hovedstaden

Job date

Thu, 21 Aug 2025 05:10:55 GMT

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