Post Basic Pharmacist Assistant
1 week ago
**Regulatory pharmacist assistant roles and responsibilities includes, but are not limited to**:
- Provide Support to the Pharmacists
- Creating and updating the required documents (Company SOP's, SMF's etc.)
- Import and Export Permit Applications
- Management of Samples
- Management of dossier information, assisting with information flow between the company and other parties/suppliers
- Updating of Regulatory Trackers (Dossiers being prepared for submission, Dossiers in Registration, Registered Products)
- Assisting with Registered Product Amendments, and any extraordinary Product changes
- Assisting with Communication with the Health Authority/ies
- Managing internal communication, within the company, between the Regulatory, Sales, and Marketing teams
- Assisting with Batch Release of Products, and Post-Importation Testing
- Maintaining Product Dossier Files and Master Documentation
- Managing Compliance with the Law (Artwork, Marketing Material, Detailers, Adverts etc)
- Proficient in more than one language (English and one additional language, preferably Afrikaans for reviewing Professional Information and Patient Information Leaflets)
- Product Resource Code and Barcode Management
- Assisting with TQA's (Technical Quality Agreements)
- Preparing company files for Audit's and Inspections by other companies, and/or Health Authorities
- Assisting with the Audits of third parties (eg: IHS, other wholesaler)
- Assisting with the management of Pharmacovigilance, and/or Medical issues
- Liaising with Licensors to get updates on dossiers in development
- Arrange payments for submission of files to the regulatory agents
- Facilitate payments for retention of products
- Handling of parcels/samples to be couriered
- Tracking outstanding responses from principals
- File marketing details aids and ensure that materials are approved
- Willing to assist any other department in the company and willing to learn and adapt to new roles and responsibilities as they arise
- Any other reasonable duties
- General all-rounder.
Ability to commute/relocate:
- Cape Town, Western Cape: Reliably commute or planning to relocate before starting work (preferred)
**Education**:
- Diploma (preferred)
**Experience**:
- Regulatory: 1 year (preferred)
- work: 3 years (preferred)
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