Regulatory Affairs Specialist

9 hours ago


Hørsholm, Hørsholm Kommune, Denmark ALK-Abelló AS Full time
Job Description

You will be working in the Regulatory CMC team at our Head Office. The team consists of 11 employees who are part of Global Regulatory Affairs.

In this role, you will be responsible for:

  • 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 and negotiating 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 a 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.
Requirements

To succeed in this role, you should have a Master of Science, e.g., in pharmacy, engineering or another relevant discipline. You should also have experience with regulatory CMC submissions and basic knowledge of the pharmaceutical industry and GMP.

Furthermore, you should be able to thrive in scientific discussions, be structured and enjoy preparing clear and logically organised written material on complex scientific matters. Your strong planning skills will also come into play, as there are several parallel activities and deadlines to manage in your role.

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



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