Senior Regulatory Professional – Regulatory Clinical, Non-Clinical & Operat

at  ALKAbell

O
ne of ALK’s important strategic priorities are to build a portfolio in anaphylaxis, and for our adrenaline business we are looking for a regulatory colleague to manage various regulatory activities. You will join the team Injectables, Drops, Diagnostics and Devices in the department Regulatory Clinical, Non-clinical & Operations (RCNO) which is part of Global Regulatory Affairs, Safety & Pharmacovigilance. You will be based in our Head Office in Hørsholm. The working environment is informal and flexible.
The role is of strategic importance, and we prefer applicants with expertise in EU regulatory procedures. You have a can-do attitude to steer a submission team with the main goal of submitting the right documentation at the right time. The ideal candidate also has regulatory experience in new drug development.
Your responsibilities will depend on your experience. Your daily tasks will cover preparation of regulatory 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 among others:

• Be responsible for reviewing, compiling and maintaining regulatory clinical and non-clinical documentation for initial and life cycle submissions for strategic product(s).
• Have cross-functional and external cooperation related to product life cycle activities.
• Be responsible for having an overview of submitted and approved clinical and labelling documentation globally.
• Update and maintain Summary of Product Characteristics (SmPCs), Package leaflets (PLs) and Printed Packaging Material and ensure timely implementation.
• Handle educational materials for drug/device combination product.
• Take part in discussions on regulatory strategies.
• Provide regulatory guidance for various cross-functional areas (e.g. clinical development, commercial operations, safety & pharmacovigilance).

YOUR QUALIFICATIONS

You have a Master of Science within a relevant field, e.g., in pharmacy, engineering preferably combined with working experience within regulatory submissions. 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 the pharmaceutical industry including GxP.
• Openness towards other departments and external stakeholders as well as a great sense of humour.
• Service-minded and a profound team-player.
• 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 in our office in Hørsholm but we also provide a degree of flexibility to work from home.

• Be responsible for reviewing, compiling and maintaining regulatory clinical and non-clinical documentation for initial and life cycle submissions for strategic product(s).
• Have cross-functional and external cooperation related to product life cycle activities.
• Be responsible for having an overview of submitted and approved clinical and labelling documentation globally.
• Update and maintain Summary of Product Characteristics (SmPCs), Package leaflets (PLs) and Printed Packaging Material and ensure timely implementation.
• Handle educational materials for drug/device combination product.
• Take part in discussions on regulatory strategies.
• Provide regulatory guidance for various cross-functional areas (e.g. clinical development, commercial operations, safety & pharmacovigilance)