Regulatory Affairs Pharmacist

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Irfa******

  • South Africa 
  • Last Update: 05.04.2019 at 12:00

Job Type
Full Time
Start
ASAP
Duration
7 Month +
Place
Pretoria Area, South Africa
Country
South Africa

Category


General Administrative

Description


Minimum Requirements
  • Bachelor of Pharmacy qualification
  • Current registration with the South African Pharmacy Council
  • Thorough knowledge of PIC/S cGMP principles
  • Computer Literacy (MS Office, SAP, etc.)
  • Thorough understanding of the laws and regulations governing registration of medicines in the applicable territories. – SADAC countries.
  • Previous working experience in preparing and submitting dossiers within the SADAC countries, as well as amendment applications
  • Must be fluent in English, Portuguese and Afrikaans are advantageous.
  • Minimum 5 years’ experience in Regulatory Affairs.
Specific Operational Requirements
  • The successful candidate will be required to work an 8 hour day.
  • The successful candidate may be required to work overtime to meet the business needs
  • Travel may be required to meet business needs
Key Performance Areas
  • Batch documentation review for final product release
  • Initiate batch related investigations, as required.
  • Compile Annual Product Quality Reviews per product
  • Provide in-house training
  • Deputise for the Responsible Pharmacist and acts as back-up for Responsible Pharmacist in their absence
  • Assists the Responsible Pharmacist in maintaining a positive relationship with all relevant stakeholders internally and/or externally
  • Assist in ensuring continuous oversight of manufacturing processes
  • Assists the Responsible Pharmacist in maintaining a state of inspection readiness
  • Provide pharmaceutical support in decision making processes
  • Developing and formulating technical product dossiers.
  • Participating in the registration strategy.
  • Evaluating the technical information and data package to support product registration.
  • Interacting with the regulatory authorities.
  • Interacting with local researchers and specialist in the different segments as well as contracted laboratories and consultants.
  • Ensure the CMO remains GMP compliant and complies with all local legislation and requirements as per the product dossiers
  • Printed Packaging Material Review
  • Marketing Material review
  • Pharmacovigilance Reporting
  • Handling of Customer Complaints
Competencies
  • Attention to Detail
  • Initiative
  • Good Communication & Interpersonal Skills
  • Analysis
  • Tenacity
  • Integrity
  • Sound ability to communicate effectively across all levels.
  • Goal Driven
  • Able to work independently

Seniority Level

Entry level

Industry

  • Pharmaceuticals

Employment Type

Full-time

Job Functions

  • Product Management
  • Quality Assurance

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