Senior Lead Regulatory Professional – Regulatory Clinical, Non-Clinical & Operations

Do you have experience working with regulatory submissions? Do you like being the one who unties key stakeholders to tell a story of the drug development to the health authorities and ensure regulatory approval of the dossier? Do you have an eye for detail but also capable of seeing the bigger picture? Then you are the right person to apply for this position!

The position
For our house dust mite tablet registered globally we are looking for a regulatory colleague to manage regulatory clinical activities. You will join Tablets & Next Generation Team in Regulatory Clinical, Non-clinical & Operations which is part of Global Regulatory Affairs, Safety & Pharmacovigilance, and you will be based in our Head Office in Hørsholm. The working environment is informal and flexible. Sharing of learnings and supporting each other in our busy everyday life in the team is key and highly appreciated.

The role is of strategic importance, and we prefer applicants with expertise in EU regulatory procedures. You have a can-do attitude to steer submission team with the main goal of submitting the right documentation at the right time. The ideal candidate should also have regulatory experience in new drug development (i.e. biologics/new chemical entities).

Your responsibilities will depend on your experience. Your daily tasks will cover preparation of regulatory clinical 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 of regulatory clinical documentation for initial and life cycle submissions for strategic product(s).
• Be responsible for having an overview of submitted and approved clinical and labelling 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 clinical area in regulatory working groups and cross-functional project teams as relevant.
• Take on regulatory responsibility for compiling the clinical part of global applications and running life cycle submissions.
• Propose, present and sometimes also execute the right strategy for clinical documentation (e.g. product labelling) to support regulatory submission.
• Evaluate regulatory impact for clinical and labelling changes.
• Provide regulatory guidance for various cross-functional areas (clinical development, marketing, safety & pharmacovigilance).
• Monitor global regulatory requirements and conduct regulatory impact assessment related to clinical area.

Your qualifications
You have a Master of Science, e.g., in pharmacy, engineering, biology or other relevant discipline combined with working experience within regulatory submissions preferably on 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 including GxP.
• 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 in our office in Hørsholm but we also provide a degree of flexibility to work from home.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 30 October 2024.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We evaluate applications and call for interviews on an ongoing basis, so don't wait to apply! We reserve the right to take down the advert when we have found the right candidate.

Do you want to learn more about our company, we encourage you to visit us at www.alk.net. For further information regarding the position please contact Director, Lilia Nicolaeva Lisdorf on +45 22 37 72 48.

We are looking forward to hearing from you!