Regulatory Affairs Pharmacist

4 days ago

Cape Town, South Africa Recruitment Matters Africa Full time

/ legislations pertaining to cosmetics and supplements range, including worldwide registration of products.

**Responsibilities**:

- 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 authorises 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 authorises 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.

**Key Skills**:

- Knowledge on legislations governing cosmetic products and supplements,
- Able to synthesize complex information and convert it into a comprehensible manner,
- Excellent writing skills,
- Excellent communication skills,
- Critical thinking,
- Reading comprehension,
- Time management,
- Excellent analytical and presentation skills,
- Attention to detail and accuracy,

**Qualifications**:

- B.Pharm. Regulatory Affairs course in cosmetics would be beneficial.
- 3 years’ experience in a pharmaceutical/cosmetic manufacturing environment in a Regulatory Affairs

position.

**Salary**: From R10,000.00 per month

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