- Review and approve any relevant documents
- Liaise with relevant internal and external customers for information or documentation required.
- Ensure input of accurate, relevant information into various RA systems.
- Evaluate data generated for amendments of products.
MAINTENANCE OF DOSSIER REGISTRATION STATUS:
- Compile the required regulatory documentation in compliance with requirements, within the allocated timelines, ensuring quality and compliance of documentation for submission of post-registration amendments.
- Compile post-registration amendments to the product dossier in compliance with the current guidelines and regulations.
- Identify and obtain any information that is outstanding in order to complete the post-registration amendment
- Ensure that documentation to support all post-registration amendments is available and that the required status / tracking documents are up to date.
- Respond to Regulatory Authority resolutions by researching and collating data to expedite approval.
- Ensure that the appropriate fees are paid.
- Ensure that documentation is dispatched in the appropriate manner and that delivery to the MCC is followed up and confirmed.
- Manage amendments’ due dates effectively.
- Ensure that all regulatory documentation is updated and that the required superceding takes place so that an accurate reflection of the current status of the product is always maintained.
- Complete all administrative functions in order to support and accurately reflect the current status of the product details within the dossier. Update and maintain all appropriate tracking documents as required to ensure accuracy and currency.
SUPERSEDING OF DOSSIERS:
- Dossiers to be superceded accurately and within the specified timeframes
- Participate in RA projects as identified.
- Supply relevant regulatory information to our internal and external customers, as required.
- All queries are followed up and strictly within policy framework.
- A professional attitude is displayed when responding to a customer’s needs.
- Internal and external customers are updated as to the progress of their queries.
- Effective communication with all internal and external customers.
- Artwork review and approval.
- Assist with problem solving to facilitate decision making and guidance.
- Follow up with the MCC on the status of outstanding submissions, as required.
- Ensuring escalation of critical issues.
- Time management;
- Problem solving;
- Analytical skills;
- Service orientation;
- Interpersonal skills;
- Report writing skills;
- Written and Verbal Communication skills;
- Bilingual (English & Afrikaans) is advantageous.
- Customer focused;
- Interpersonal sensitivity;
- Attention to detail;
- Logical thinking;
- Information seeking;
- Sense of urgency.
- MCC and any other relevant regulatory requirements;
- Principles governing regulatory requirements such as GMP, ICH and SUPAC guidelines on stability, validation of various processes, equipment classification;
- Knowledge of dossier compilation and requirements;
- Knowledge of how Pharmaceutical Industry operates;
- Knowledge of the contents of the different Acts and Regulations governing Pharmacy;
- Knowledge of project management principles.
EDUCATION & EXPERIENCE:
- Matric / Grade 12;
- Bachelor of Pharmacy degree or equivalent;
- Regulatory Affairs training and certification a distinct advantage;
- 1 year + experience within the pharmaceutical industry in a regulatory Affairs/ Production/ Quality/ Clinical environment is preferable.