We are currently looking for a Regulatory Affairs Manager to join the team at our client's.
Support implementation locally of new initiatives, management tools or processes in cooperation with EST- RA.
Ensure that processes, procedures and regulatory files are well documented in up to date and complete applicable archives, databases, repositories and trackers.
Contribute to the EST-RA and affiliate Quality Management System. Ensure compliance with all applicable SOPs, WPDs and STLs and contribute to CAPAs in case of gaps and deviations.
Secure timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention via the RA lead to the Management Team, such as deletions, divestitures and acquisitions.
Take part in affiliate product and launch teams to provide regulatory input and strategy advice.
MS Degree in Pharmacy or other Life Science or equivalent by experience.
A minimum of 3-4 years experience in a Registration Department
Proficiency in local and English language
Proficiency in PC use with regard to word-processing, spreadsheets, database application, and internet.
Ability to communicate well verbally and in writing is essential
A sound appreciation of the interactions and relationships of the department with other internal departments is expected.