Regulatory Affairs Specialist

Location: Oss

The Regulatory Affairs (RA) Specialist within the Development & Manufacturing department, ADS Licensing, is responsible for the preparation, review, and maintenance of high-quality regulatory submission documents describing the chemistry, manufacturing, and controls (CMC) aspects of GlycoConnect® and other ADS Licensing components throughout their lifecycle. Working closely with customers and cross-functional teams—including development, manufacturing, quality, clinical, and regulatory strategy — the RA Specialist ensures a consistent and phase appropriate filing strategy. The RA Specialist further assures that all CMC information complies with global regulatory requirements (FDA, EMA, PMDA, MFDS, sFDA, Health Canada, etc.) and supports timely DMF and other filing approvals, post-approval commitments, and life cycle management activities.

What you will get: