Regulatory Affairs Pharmacist

5 months ago

Cape Town, South Africa Recruitment Matters Africa Full time

**Responibilities**:

- Investigates and interpret the regulatory and legislative needs globally and summarize 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 new barcodes on request per template.
- Maintains the barcodes list by issuing new barcodes on request per template.
- Sources and summaries of 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 with 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 reviews 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 requests 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 ensures 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 of legislation 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.
- Work independently
- Assertive
- Professional
- Competent

**Qualifications**:

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

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