Scientist Regulatory Affairs

1 week ago


Cape Town, South Africa Tych Business Solutions Full time

RESPONSIBILITIES

Assist with amendments under the guidance of the divisional manager
Raise CCP’s and report on the status and implementation thereof
Assist with the compilation and implementation of safety updates
Assist with the compilation of baseline dossiers as and when required
Assist with the compilation of queries from SAHPRA
Assist with the queries and correspondence relating to product launch meetings and new product launches
Assist with obtaining the relevant information for any QA related queries
Liaise with supply and marketing on any product related queries
Liaise with suppliers on dossier related queries
Assist with dossier technical queries with the guidance of line management
Assist Compliance with technical queries as and when required
Monitor the Change Control process effectively
Assist with monthly reporting on RA export activities and deliverables
Ensure departmental training sessions are attended and recorded
Assist with the compilation and updates of SOP’s as and when required

Assist Compliance with the circulation of printed packaging components as and when required
Assist compliance with obtaining the relevant information to compile an artwork pack as and when required
Assist with and monitor the implementation of QR codes
Assist with any queries relating to printed packaging components

**REQUIREMENTS**:
Relevant B Sc. degree, preferably at post-graduate level
Minimum of 12 months Regulatory experience
Able to perform all standard registration processes under specialist guidance


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