Regulatory Professional

2 days ago

Hørsholm, Denmark ALK-Abello Full time

Do you have interest in regulatory chemistry, manufacture and control (CMC) activities for strategic tablet products registered globally? Do you thrive in scientific discussions on complex scientific matters? Are you experienced working with regulatory CMC submissions to the authorities globally?

The position
You will join the Regulatory CMC, Tablets and Next Generation team consisting of 11 employees based at our Head Office in Hørsholm. You will be part of an engaged team who values your skills and creativity, where the working environment is informal and flexible. The team forms part of Global Regulatory Affairs.

Responsibilities:

  • Preparing regulatory CMC documentation and handling submissions to authorities globally.
  • Scientific/technical writing and maintaining regulatory CMC documentation for initial and life cycle submissions for strategic products.
  • Having an overview of submitted and approved CMC documentation globally.
  • Ensuring cross-functional and external cooperation related to product life cycle activities.
  • Communicating, coordinating, negotiating, and aligning regulatory strategies as representative for regulatory CMC in regulatory working groups and cross-functional project teams.
  • Taking on regulatory responsibility for compiling the CMC part of global applications and running life cycle submissions.
  • Establishing the right strategy for CMC documentation and submission.
  • Evaluating regulatory impact for CMC changes.
  • Providing regulatory guidance for various cross-functional areas.
  • Monitoring global regulatory requirements and conducting regulatory impact assessment related to CMC.

Your profile
You have a Master of Science, e.g., in pharmacy, engineering or another relevant discipline and you have experience with regulatory CMC submissions and basic knowledge of the pharmaceutical industry and GMP.

You thrive in scientific discussions with the goal of clarifying needs and identifying solutions. You are structured and you enjoy preparing clear and logically organised written material on complex scientific matters. As there are several parallel activities and deadlines to manage in your role, your strong planning skills will also come into play. You take responsibility for getting the job done, are results oriented and can keep the perspective in times of increased activity.

Furthermore, you possess excellent communication and stakeholder management skills, and you master English at a high professional level, both in writing and orally.

Become a part of ALK
ALK is a global pharmaceutical company specialised in allergy immunotherapy. We provide an attractive working environment for individuals looking for both personal and professional development. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with our colleagues.

Global Regulatory Affairs at ALK provides a uniquely 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 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 from time to time.

Apply
Apply by attaching your CV and a short letter of motivation, no later than 8 September 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 are looking forward to hearing from you

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