Regulatory Affairs Section Head At GSK
Are you looking for an opportunity to support a regulatory environment where you will be a part of cost reduction initiatives and ensure submission of packages are generated and provided to markets? If so, this is the role for you.
As a Regulatory Section Head, you will be responsible for ensuring Ensure site regulatory compliance with all Egyptian drug authorities (EDA) requirements. Preparing registration dossiers for local and export markets. Issuing and legalizing CPP&GMP certificates for export markets. Ensure new product specifications are complying with registered details ,prepare variations packages and suppliers files. Submission of renewal & registration packages for export in addition to a timely response to regulatory authority’s queries. Ensure the alignment of registered information with current site practices. Handle regulatory documents required for tenders.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Prepare registration dossiers for local and export markets and maintain good archiving system.
Ensure product specifications are complying with registered specs.
Prepare and Submit site registration application/ form submission, renewal & registration packages for export (dossiers, POA, declarations, samples, CPP, GMP, EDA applications. …etc)
Issue and control certificates of pharmaceutical product (CPP) and GMP certificates to accomplish registration in export and follow up their legalization after evaluation and revision by the authorities: Ministry of Health, Ministry of Foreign Affairs, embassies…….etc.
Prepare registration dossiers for addition of suppliers to MA.
Ensure the alignment of registered information with actual processes and current practices.
Fulfil regulatory authorities requirements (Post approvals, renewal requirements, new Guidelines….etc)
Review and approve COAs of FP to comply with registered details for local and export markets that will be submitted to regulatory authorities.
Conduct L1 inspections on regulatory department according to planned schedule, make the use of GPS tools for effective performance and on-going improvement in ways of working. Ensure that EHS policies and procedures are implemented during work.
Prepare and conduct the sealing process for finished goods ,APIs (including Narcotics if any) through follow up with all relevant stakeholders.
Direct interaction – handling – communication with MOH/ EDA (Egyptian drug authorities).
Ensure site compliance with EDA requirements/guidelines.
Prepare random sealing plans with logistics and submit samples with all relevant documents at CADC (Nodcar) till archiving of Nodcar comply.
Responsible for site variations submissions and updating registration data to local EDA following CCR's and regulatory changes.
Coordinates with research and BE centres ex: (Faculty of Pharmacy and GRC, etc.) a to perform requested studies needed by EDA (e.g. Bioequivalence, new MOA, clinical reports, toxicological reports, chemical experts reports, vitro dissolution, etc).
Deliver rejected finished goods, raw material or bulk disposal submitted by warehouse to the EDA for verification and approval
CTD Module 2-3 preparation will be of added value
In case of tender ,provide a copy of all required documents related to the job as CADC conformities to the sales and distribution sections at the EDA.
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.)
Manage retain of parallel samples till CADC compliance received
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s Degree from faculty of Science or Pharmacy.
Minimum 3 - 5 years' Experience in similar role or senior specialist, preferably within a multinational pharmaceutical company.
If you have the following characteristics, it would be a plus:
Excellent Excel capabilities
Good Team working skills
Good communication and analytical skills
Good command of English language (spoken and written) as well as excellent Excel capabilities