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Regulatory Affairs Pharmacist
2 weeks ago
Responsibilities:
- 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,
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
- Ensures international and national legislations are adhered to by reviewing standards versus dossiers as
- Manages the lifecycle of the company product registrations in accordance with Legal and Regulatory
- Ensures that any products registered as pharmaceuticals are sufficiently controlled, and that the correct
- Requests product information or declarations from R&D and generates as per template, the SDS for
- 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
- Prepares information needed for Quality Management System's review meeting by trending regulatory
- 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
- Checks all artwork to ensure regulatory requirements are met globally by using the Brand specification
- 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
- 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
Salary:
From R10,000.00 per month
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