Q & a Chemist

**Regulatory Affairs Pharmacist**

**Parow**

**R55-65 000.00 with medical Aid, pension and 13th cheque**

**Join an international, reputable and stable manufacturing pharmaceutical company within the skin care department.**

**Requirements**:

- B.Pharm. Regulatory Affairs in Cosmetics or Pharmaceutical
- Relevant manufacturing experience in either above mentioned industries
- Experience working within a quality Assurance department

**Duties**:

- Investigates and interprets the regulatory and legislative needs globally and summaries the requirements
- 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.
- 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,
- 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.
- 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.

**Job Types**: Full-time, Permanent

**Salary**: R55,000.00 - R65,000.00 per month

**Education**:

- Bachelors (preferred)
**Experience**:

- Chemist: 5 years (preferred)
- Q & A Chemist: 3 years (preferred)
Work Remotely:

- No