Regulatory Affairs Professional
We are looking for two new colleagues to our Regulatory CMC department. We are a team of 9 people handling CMC documentation for ALK tablet portfolio. The team is part of Global Regulatory Affairs which counts approximately 50 people in Hørsholm.
We are looking for two team members that are dedicated to communication of complex scientific matters in a written form. We believe you have experience with global regulatory CMC requirements for biological products and Regulatory Life Cycle Management of medicinal products globally. We also hope you enjoy cross-functional interactions.
Field of responsibility
- Responsible for writing and maintaining regulatory CMC documentation for worldwide submissions
- Responsible for having an overview of submitted and approved CMC documentation in different regions
- Cross-functional cooperation related to product life cycle management
- Responsible for life cycle CMC submissions
- Establishment of the right strategy for CMC documentation and submission
- Provide regulatory guidance for various cross-functional areas.
Overall responsible for CMC lifecycle activities for one of ALK allergy immunotherapy tablets.
Support to CMC lifecycle activities for ALK allergy immunotherapy tablets registered world wide.
- A Master of Science, e.g. in pharmacy, engineering or other relevant discipline
- Thrive on scientific discussions with the goal of clarifying needs and identifying solutions
- Experience with regulatory CMC requirements and eCTD
- Open towards other departments and external stakeholders
- Enjoy preparing clear and logically organised written material on complex scientific matters
- Excellent communication skills, written and orally
- Result oriented and able to keep the perspective in times of increased activity
- Excellent writing skills in English
- Experience with SharePoint will be an advantage
- Experience with CMC development or manufacture in the pharmaceutical industry will be an advantage.
- Experience with regulatory lifecycle activities in EU, US and Canada for biological products
- Experience with regulatory CMC, preferable > 3 years.
- Experience with regulatory CMC and/or regulatory lifecycle management will be an advantage.
ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be 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. You will be part of an engaged and informal team who values skill and knowledge creation. We consider our pioneering spirit coupled with our trustworthiness our winning formula. ALK is a health focused organization and our offices offer a green view of the DTU Scion science park in Hørsholm.
For further information please contact Manager Dorte Friis Christensen +45 2145 3919.
How to apply
Please click on apply and kindly remember to attach a letter of motivation and CV. Application deadline is March 12 but we will evaluate applications on an ongoing basis. Please indicate if you have a preference for one of the two positions. We are looking forward to hearing from you.
ALK is a global research-driven pharmaceutical company focusing on allergy prevention, diagnosis and treatment. We are the world’s leading company within allergy immunotherapy. We are constantly moving forward as we have maintained our pioneering spirit. We are large enough to offer you both challenges and good opportunities for development, but not large enough for you to disappear in the crowd.
We have experienced success and significant growth in recent years, and together with our international partners we work to expand the use of allergy immunotherapy worldwide. Therefore we need employees who both desire and are capable of influencing the company.
Read more about our vacancies at www.alk-abello.com/career.