Lead Regulatory Professional – Combination Products

at  ALKAbell

F
or our injectable Drug-Device Product (Jext®) registered globally we are looking for a regulatory colleague to manage regulatory CMC activities. You will join the Regulatory CMC, Injectable, Devices and Drops team which is part of Global Regulatory Affairs, and you will be based at our Head Office in Hørsholm. The working environment is informal and flexible, and sharing of learnings within the team is very important for us.
The role is of strategic importance, and we prefer applicants with Drug-Device expertise.
Your responsibilities will depend on your experience. Your daily tasks will cover preparation of regulatory CMC documentation and handling of the submissions to authorities. As there are several parallel activities and deadlines to manage your good planning skills will come into play.

In this role you will:

• Be responsible for scientific/technical writing and maintaining regulatory CMC (Chemistry, Manufacture and Control) documentation for initial and life cycle submissions for strategic product(s).
• Be responsible for having an overview of submitted and approved CMC documentation globally.
• Have 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.
• Take on regulatory responsibility for compiling the CMC part of global applications and running life cycle submissions.
• Propose, present and sometimes also execute the right strategy for CMC documentation and submission.
• Evaluate regulatory impact for CMC changes.
• Provide regulatory guidance for various cross-functional areas.
• Monitor global regulatory requirements and conduct regulatory impact assessment related to CMC.

YOUR QUALIFICATIONS

You have a Master of Science, e.g., in pharmacy, engineering, biology or other relevant discipline combined with working experience within regulatory CMC submissions preferably in a global scale. You thrive in scientific discussions with the goal of clarifying needs and identifying solutions, and you enjoy preparing clear and logically organised written material on complex scientific matters.

Moreover, we expect:

• Basic knowledge from within the pharmaceutical industry as well as GMP.
• Openness towards other departments and external stakeholders as well as a great sense of humour.
• Excellent communication skills and good English skills, both in writing and orally.
• Taking on responsibility for having the job done and being well structured and organized.
• Result oriented and able to keep the perspective in times of increased activity.

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 specialized 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 part of an engaged and informal team who values skill and knowledge creation.
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 with a degree of flexibility to also work from home.

• Be responsible for scientific/technical writing and maintaining regulatory CMC (Chemistry, Manufacture and Control) documentation for initial and life cycle submissions for strategic product(s).
• Be responsible for having an overview of submitted and approved CMC documentation globally.
• Have 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.
• Take on regulatory responsibility for compiling the CMC part of global applications and running life cycle submissions.
• Propose, present and sometimes also execute the right strategy for CMC documentation and submission.
• Evaluate regulatory impact for CMC changes.
• Provide regulatory guidance for various cross-functional areas.
• Monitor global regulatory requirements and conduct regulatory impact assessment related to CMC