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.
Provide format and contents review of packaging texts, Summary of Product Charact...