Regulatory Affairs Pharmacist

2 weeks ago

Cape Town, Western Cape, 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 nonconformances 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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