Regulatory Affairs Specialist for Strategic Tablet Products
1 day ago
Global Regulatory Opportunities
">Are you interested in the intersection of scientific and regulatory affairs? Do you thrive in discussions on complex chemistry, manufacture, and control (CMC) activities?
">About the Role
">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:
">- 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
">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:
">- 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
">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.
">Join Our Team
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