Regulatory Affairs Specialist

A Specialist profile will ensure efficient project execution, better quality outcomes, and reduced dependency on supervision. Therefore, hiring a Specialist is essential to meet the role requirements effectively.

MAIN ACTIVITIES FOR THE JOB

• Contribute to regulatory activities performed on the RA Platform/the Hub
• Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers.
• To contribute to the production of client administrative documents and reports to be included in regulatory submissions.
• Support for Initial MA application, all kind of LCM activities.
• Act as (Single) Point of Contact and oversee clients’ portfolios.
• Cross-functional co-ordination.
• Communication with external vendors.
• Communication...