Regulatory Affairs Pharmasist - Cape Town, South Africa - NRS Recruitment

NRS Recruitment
NRS Recruitment
Verified Company
Cape Town, South Africa

2 weeks ago

Thabo Mthembu

Posted by:

Thabo Mthembu

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Description

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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