Manager/Director within Regulatory CMC, Global Regulatory Affairs

Are you experienced within the Regulatory CMC area taking a strategic perspective in handling CMC documentation for pharmaceutical products? Are you an inspiring leader and a skilled people manager? Join us in making a difference for people living with allergy!

The position
Regulatory CMC is an area within Global Regulatory Affairs organised in 4 teams sharing the responsibility for the regulatory quality documentation of ALK products. You will in the position as Manager be responsible for one of these teams with 10 skilled regulatory employees focusing on Sublingual Immunotherapy Product and take seat in the global Regulatory Management Team. 

Your primary tasks will be:

• People Management: Lead, mentor and inspire the employees.
• Regulatory Strategy: Participate in defining the CMC regulatory strategies for both early product development, marketing authorization for new products/new markets and product maintenance.
• Stakeholder Management: Ensure alignment with other teams in Global Regulatory Affairs and key stakeholders withing CMC Development, Product Supply and Quality Assurance.

Your profile
We expect that you have:

• Relevant scientific education with focus on chemistry and biology.
• Experience with people management and good cooperation skills.
• Experience with CMC documentation for pharmaceutical products.
• Knowledge of regulatory procedures for pharmaceutical products worldwide.
• A good sense of humour and appreciate to be challenged.

Become a part of ALK
We provide an attractive working environment for individuals looking for both personal and professional development. ALK is a global pharmaceutical company specialised in allergy immunotherapy. We are driven by a high level of professionalism, integrity, an openminded approach and contributing to an inspiring and fun working environment together with our colleagues. You will be leading an engaged team that has an informal communication and where skills and creativity comes into play. The result of your efforts will be significant throughout the organisation, and you will be able to actively influence and challenge the status quo.

Our offices in Denmark offer a green view of the DTU Science Park in Hørsholm. We believe that physical presence enforces strong teamwork and collaboration and creates success, so it is important that you enjoy coming to work at our site, but we also have flexibility to work from home.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 19 May 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 www.alk.net. For further information regarding the position please contact Senior Director, Stig Grell by phone +45 41290705.

We are looking forward to hearing from you!