Job Description
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.
- P...