Emerging Search Consultants
We are an International Recruitment Firm. We do niche recruitment and specialise in engineering, fmcg, oil & gas, sales & marketing, legal, financial, IT and HR recruitment Recruiter from sector Engineering, located in Gauteng, From 1 to 10 workers
- Johannesburg, City of Johannesburg, Gauteng
Senior Regulatory Affairs Pharmacist
A multinational South African holding company for pharmaceutical concerns seeks a Regulatory Affairs Senior Pharmacist
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.
Manage amendments�€� due dates effectively.
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.
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.
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.
SUPERSEDING OF DOSSIERS:
Dossiers to be superceded accurately and within the specified timeframes
Participate in RA projects as identified.
Supply relevant regulatory information and regulatory intelligence 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.
Peer review of colleagues�€� submissions.
Assisting with training of current and new employees.
Assisting with updating of workflows and work instructions.
Follow up with the MCC on the status of outstanding submissions.
Ensuring escalation of critical issues.
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:
Bachelor of Pharmacy degree or equivalent, with Regulatory Affairs training and certification a distinct advantage;
Minimum 3 �€� 4 years Regulatory experience required;
In addition, 3 �€� 4 years�€� experience within the pharmaceutical industry in a production/ Quality/ Clinical environment would be an advantage.
Please note that due to the high volume of applications, we cannot respond to every applicant. If you have not heard from us within 48 hours then unfortunately, you are unsuccessful. We will however keep your details on file for when something suitable comes up.
- Language(s): English
- Availability for travel: No
- Availability for change of residence: No
About this job ad 17 August
Type of contract
Type of contract
Type of contract