Regulatory Affairs Professional

ALK-Abelló A/S


ALK is on an ambitious journey to become the preferred allergy company globally and this is why we are looking for a new colleague to join us.

The position
Are you dedicated to Regulatory Affairs? Are you dedicated to communication of complex scientific matters in a written form? Do you have experience with requirements for biological products and Regulatory Life Cycle Management of medicinal products globally? Do you enjoy cross-functional interactions?

Then you might be our new colleague within the Regulatory CMC Department of Global Regulatory Affairs. The Regulatory CMC area counts 34 employees organized in four teams, hereof three in Hørsholm. The open position is placed in RA CMC Injectables, Drops and Devices in Hørsholm.

Fields of responsibility

  • Provide regulatory guidance in cross-functional teams related to product optimization and strategic expansion
  • Establish the right strategies for CMC documentation and submission for Life Cycle Submissions
  • Lead global CMC submissions including writing and maintaining CMC part of regulatory dossiers
  • Ensure overview of submitted and approved CMC documentation in different regions
  • Monitor global regulatory requirements related to biological products

Your qualifications

  • A Master's degree in pharmaceutical science, engineering or other relevant discipline
  • Experience with global regulatory requirements for biological products
  • Ability to establish regulatory strategies and the right documentation level
  • Thrive on scientific discussions with the goal of clarifying needs and identifying solutions
  • Open towards the needs of other departments and external stakeholders
  • Skilled in preparing clear and logically organized written material on complex scientific matters
  • Excellent communication skills, written and orally
  • Value teamwork and prefer meeting challenges as a team
  • Result oriented and able to prioritize when the workload increases

The department/team
In Global Regulatory Affairs, we provide an attractive working environment for Regulatory Affairs Professionals looking for both personal and professional development. ALK is a global pharmaceutical company in progress offering unique job opportunities. You will be part of a dynamic and dedicated team who continuously strive to improve.

ALK provides a uniquely dynamic and pleasant working 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 Science Park in Hørsholm.

Allergy Solutions For Life
More than 500 million people worldwide have allergies. Many of them suffer in silence because the way ahead is too confusing.

By collecting information and the latest and most trusted solutions together in one place, we want to make allergy surprisingly simple to manage. With 100 years of experience, nobody knows allergy like us, and we continuously apply our scientific knowledge and expertise to help people take control of their allergy and their life.

We want to make a difference by offering solutions for everyone who is touched by allergy – through a comprehensive range of products, services and resources that offer a fast-track to a more balanced life.

By joining ALK you will get the opportunity to be part of our exciting journey where you are able to create results, develop solutions, yourself and ALK together with highly skilled and engaged colleagues while helping millions of people suffering with allergy.

For further information on the position please contact Manager Tina Meinertz Andersen (+45 5089 9503).

How to apply
Please click on apply and kindly remember to attach a letter of motivation and CV. We are looking forward to hearing from you.

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