Regulatory Affairs, CMC Manager

ALK-Abello A/S

ALK is a company that helps people living with allergy, and it is their ambition to remain the Word leader in allergy. To fulfil this, they need the best talent to join the organisation. Therefore, we are searching for a new colleague in Global Regulatory Affairs, where you will be Manager for a team within the Regulatory CMC department. If you like to have influence and make a difference, ALK is the right place to be, so come join ALK on their exciting journey.

Take the lead on regulatory CMC activities and empower your team
There are currently 10 employees in the team, consisting of Regulatory Professionals and Coordinators, who are CMC responsible for a portfolio of Allergy Immune Therapy products and a drug/device combination product. You will lead and develop an ambitious and highly skilled team, who are responsible for all relevant CMC regulatory activities. Reporting to the Senior Director, Regulatory CMC, you will provide regulatory expertise to establish regulatory strategies and to execute regulatory submissions. With your strong stakeholder management skills, you will have a close cooperation and sharing knowledge with internal stakeholders across Global Regulatory Affairs to ensure the delivery of business objectives.

Your qualifications
It is expected that you hold a university degree in life sciences or chemistry. You bring a minimum of five years of experience within Regulatory Affairs and are also experienced in people management. You have strong stakeholder management skills and are experienced in communication and negotiation with regulatory authorities and developing regulatory strategies. As a manager, you take the lead, coach your team and set the direction for strategies and goals.

What ALK has to offer
ALK offers an exciting position in an international company with solutions that make a difference for people with allergy. ALK is characterised by having a global and dynamic mindset, and the flat structure gives you the opportunity to be close to the decision-making processes and develop both your personal and professional competencies.

ALK is a global company with production sites in Denmark, France, Spain and the United States and employ around 2,300 people around the globe. The headquarter is based in Hørsholm, north of Copenhagen. ALK acknowledge that their employees are their most valuable assets and believe they do their very best to create new and better allergy treatments and solutions for people with allergy around the world.

Apply for this unique position at ALK
The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Senior Research Consultant, Tina Gissel Larsen on tel.: +45 61 20 29 45. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.

Deadline for application: As soon as possible
Workplace: Hørsholm, Denmark
Company: ALK-Abello A/S
Reference: 2005.233