Regulatory Affairs Specialist for Strategic Tablet Products

1 day ago


Hørsholm, Hørsholm Kommune, Denmark ALK-Abello Full time

Global Regulatory Opportunities

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Are you interested in the intersection of scientific and regulatory affairs? Do you thrive in discussions on complex chemistry, manufacture, and control (CMC) activities?

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About the Role

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You will join the Global Regulatory CMC team at ALK-Abello, contributing to the development and submission of strategic tablet products globally. As a key member of our team, you will be responsible for:

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  • Preparing high-quality regulatory CMC documentation and handling submissions to authorities worldwide.">
  • Scientific/technical writing and maintaining up-to-date regulatory CMC documentation for initial and life-cycle submissions.">
  • Ensuring cross-functional and external cooperation related to product life cycle activities.">
  • Representing the team 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.">

Requirements and Qualifications

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To succeed in this role, you will have a Master of Science degree in a relevant discipline and experience with regulatory CMC submissions. You will also possess:

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  • Basic knowledge of the pharmaceutical industry and Good Manufacturing Practices (GMP).">
  • Excellent communication and stakeholder management skills.">
  • High-level proficiency in English, both written and spoken.">

Becoming Part of ALK-Abello

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ALK-Abello is a global pharmaceutical company specializing in allergy immunotherapy. We offer an attractive working environment that fosters personal and professional growth. Our values include professionalism, integrity, and open-mindedness, which contribute to an inspiring and fun work environment.

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Join Our Team



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