Quality Regulatory Section Head At GSK Egypt
Job Description:
Are you a Quality Regulatory Section Head who is energized by the challenge of being part of one of the leading pharmaceutical companies worldwide? If so, this role is the one for you to explore.
As a Quality Regulatory Section Head, you will be responsible for ensuring Egypt sites (Cairo and Giza) regulatory compliance with all Egyptian drug authorities (EDA) requirements, confirming new product specifications are complying with registered details, preparing variations packages and suppliers files.
You will also be accountable on submission of renewal & registration packages for local and export in addition to a timely response to regulatory authority’s queries, and to ensure the alignment of registered information with current site practices.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Responsible for preparing the EDA required stability studies including: stability tables, chromatograms extraction , EDA specification templates, EDA declarations required.
Responsible for preparing EDA required documents for Methods of analysis, Analytical methods validation that should be submitted to EDA.
Responsible for preparing any QC COA to comply with registered details for local and export markets that will be submitted to regulatory authorities.
Ensure product specifications are complying with the latest registered specs.
Prepare and Submit site registration application/ form submission, renewal & registration packages for export (dossiers, POA, declarations, samples, CPP, GMP, EDA applications. …etc.)
Ensure the alignment of registered information with actual processes and current practices.
Fulfil regulatory authorities requirements (Post approvals, renewal requirements, new Guidelines….etc.)
Direct interaction – handling – communication with EDA (Egyptian drug authorities).
Ensure site compliance with EDA requirements/guidelines.
Responsible for site renewals, variations submissions and updating registration data to local EDA following CCR’s and regulatory changes.
Responsible for EDA site documents management and control (Keep all correspondences or documents sent or received through the company, CADC, or EDA and retain them according to GSK retention policy schedules.)
Handle regulatory documents required for tenders.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree of Pharmacy, Science, Chemistry or equivalent.
Minimum 3 – 5 Years of experience in similar role. preferably in a multinational pharmaceutical company.
Up to date knowledge of current GMP, EDA Regulatory requirements, GSK QMS System.
Excellent documentation and report writing skills.
Excellent verbal and written communication skills.
Good command of English and computer skills.
Self-motivation, empowerment and adaptation to business changes.
Strong prioritization and organization skills.