Regulatory Affairs Pharmasist

2 weeks ago

Cape Town, South Africa NRS Recruitment Full time

**Key Performance Areas**
- Investigates and interprets the regulatory and legislative needs globally and summaries the requirements as per business needs.
- Manages and is responsible for the registration of products and supplements globally by initiating, compiling, approving and submitting the necessary documents to the regulatory body as per requirements.
- Maintains the barcodes list by issuing of new barcodes on request per template.
- Maintains the barcodes list by issuing of new barcodes on request per template.
- Sources and summaries regulatory requirements for new territories.
- Initiates and actions Change controls on regulatory changes as required.
- Prepares and authorizes declarations for AUS shipments.
- Prepares and drafts an impact study on raw materials when required to ensure compliance to global regulations.
- Ensures international and national legislations are adhered to by reviewing standards versus dossiers as per alert notifications.
- Manages the lifecycle of the company product registrations in accordance with Legal and Regulatory requirements.
- Ensures that any products registered as pharmaceuticals are sufficiently controlled, and that the correct procedures governing these products are implemented.
- Requests product information or declarations from R&D and generates as per template, the SDS for finished goods, CITIES, and files SDSs electronically.
- Reviews and authorizes SOPs where required e.g., artwork updates, registration process.
- Performs annual product review as per regulatory standards by trending regulatory information and other relevant information (SAHPRA).
- Prepares information needed for Quality Management System’s review meeting by trending regulatory information as per set objectives per department.
- Implements identified actions and regulatory request as per senior management’s evaluation of risk.
- Conducts impact assessments on new/updated formulas.
- Reports monthly on regulatory updates to Quality Assurance Manager and provides progress reports when requested.
- Checks all artwork to ensure regulatory requirements are met globally by using the Brand specification sheets provided.
- Manages the External supplier audit schedule and ensure that audits are conducted as per the schedule.
- Conducts Internal and Supplier Audits as per the relevant Audit Schedule and follows up on all non
- conformances identified.
- Governs the External provider approval and monitoring process.
- Ensures that findings are resolved by communicating with relevant external providers.

**Qualifications & Experience**
- B. Pharm mandatory
- Regulatory Affairs course in cosmetics would be beneficial.
- 3 years’ experience in a pharmaceutical/cosmetic manufacturing environment in a Regulatory Affairs role.

**Applications**
- **To be considered for the position, you must have the listed requirements i.e., Competencies, Qualifications and Experience**

**Salary**: From R20,000.00 per month

**Education**:

- Bachelors (required)

**Experience**:

- Regulatory affairs: 2 years (required)

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