Regulatory Affairs Officer

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.
• Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements.
• Systems Management and Administration.
• Document and track regulatory submissions and regulatory authority approval.
• Gain regulatory authority approval.
• Provide regulatory support to clients and associate companies.
• Liaise with sponsor head-office and affiliate departments on regulatory issues.
• Liaise with external regulatory authorities as required. ...