Company Overview
The company is committed to researching and developing treatments for rare diseases. It strives to deliver high-quality medications that enhance the health and well-being of patients. As a prominent player in the orphan drug sector, the company collaborates with various partners, including its headquarters in Japan, to expand its business.
Job Responsibilities
Coordinate, prepare, and review regulatory submissions.
Manage type IA, IB, and II variations, including preparing documentation for variation packages.
Communicate with regulatory agencies about submission strategies and follow-up on submissions under review.
Maintain current knowledge of existing and emerging regulations, standards, and guidance documents.
Participate in internal or external audits.
Job Requirements
Scientific degree (preferably in Pharmaceutical Chemistry and Technologies).
3-5 years of experience in the Regulatory Affairs department.
Full knowledge of local and EU rules/regulations.
Recent experience in the biotechnology industry is strongly preferred.
Apply online or feel free to contact me directly for more information about this opportunity. Due to the high volume of applicants, we regret to inform that only shortlisted candidates will be notified. Thank you for your understanding.
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