Regulatory Affairs Professional

The position

For one of our strategic products registered globally we are seeking an experienced regulatory colleague to manage regulatory CMC activities.  You will be responsible for the preparation of the documentation and handling the submissions to authorities. As there are several parallel activities and deadlines to manage your good planning skills will come into play. 
The working environment is informal and flexible, and sharing learnings within the team is important for us.

The open position is placed in the Regulatory CMC, Tablets and Next Generation team which is part of Global Regulatory Affairs. The position is in Hørsholm, Denmark.

Fields of responsibility

• Responsible for scientific/technical writing and maintaining regulatory CMC (Chemistry, Manufacture and Control) documentation for initial and life cycle submissions for a strategic product
• Responsible for having an overview of submitted and approved CMC documentation globally
• Cross-functional and external cooperation related to product life cycle activities
• Communicate, coordinate, negotiate and align regulatory strategies as representative for regulatory CMC in regulatory working groups and cross-functional project teams as relevant
• Regulatory responsibility for compiling the CMC part of global applications and running life cycle submissions
• Establishment of the right strategy for CMC documentation and submission
• Provide regulatory guidance for various cross-functional areas
• Monitor global regulatory requirements and conduct regulatory impact assessment related to CMC

Your qualifications

• A Master of Science, e.g. in pharmacy, engineering or other relevant discipline
• Working experience with regulatory CMC submissions, preferably globally
• Thrive on scientific discussions with the goal of clarifying needs and identifying solutions
• Basic knowledge of pharmaceutical industry and GMP
• Open towards other departments and external stakeholders
• Enjoy preparing clear and logically organised written material on complex scientific matters
• Excellent communication skills, both in writing and orally
• Good English skills, both in writing and orally
• Well structured
• Takes responsibility for having the job done
• Result oriented and able to keep the perspective in times of increased activity

We offer

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.

ALK provides a dynamic and pleasant work environment, complete with inspiring and challenging assignments. 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.

Application deadline

Responders will be evaluated on an ongoing basis so don´t hesitate to apply for this position.

The application process will close at 7 March 2021.

Contact

For further information on the position please contact Manager Dorte Friis Christensen (+45 2145 3919).