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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
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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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