| Job Location | Al Kuwait, Kuwait |
| Education | Bachelor's degree / higher diploma |
| Salary | Not Mentioned |
| Industry | Other Healthcare Services |
| Functional Area | Not Mentioned |
POSITION SUMMARY:The Regulatory Affairs Officer is responsible to provide input as required at all levels within the AHC, themain responsibility is to plan and execute all activities necessary for the registration of new products andline extension indications. The Regulatory Affairs Officer ensures the appropriate licensing, marketingand legal compliance of pharmaceutical and medical products. Also assist in the releases required for allcompany products .ESSENTIAL DUTIES:1 Ensuring that a company's products comply with the regulations of the Medicines and Healthcareproducts Regulatory Agency (MHRA).2 Responsible for Pharmacovigilance activities as Qualified Personal for Pharmacovigilance.? Review all distribution agreements in this regards.? Collection of Adverse event reports.? Notify the MOH and Principals for any adverse event (AE).? Monitoring of any PV regulations.? Training employees on PV.3 Keeping abreast of international and local legislation, guidelines and customer practices.4 Collecting and collating a wide range of information, keeping up to date with a company's productrange.5 Developing and writing clear point of view and explanations for new product license and licensesrenewals.6 Preparing submissions of license variations and renewals; setting timelines for license variationsand renewal approvals.7 Understanding and evaluating complex information and planning and developing product trials;interpreting trial data and advising company?s on regulatory requirements;8 Resolving complex issues as arise; preparing and coordinating documentation;9 Project managing teams of colleagues involved with the development of new products;maintaining quality systems; undertaking and managing regulatory inspections;10 Reviewing company practices and providing advice on changes to systems;11 Liaising with, and making presentations to, regulatory authorities; submitting license and clinicaltrials applications to authorities to strict deadlines;12 Negotiating with regulatory authorities for marketing authorization.13 Specifying storage, labeling and packaging requirements, liaising closely with the regulatoryauthorities on a regular basis.14 Review of validation, development and stability reports to ensure compliance with licence detailsand relevant guidelines and directives.15 Assist in the training of new artwork and regulatory personnel.16 Communicate with all departments/division to ensure schedules are achieved. Provision ofregulatory support.17 Negotiate and ensure the best listed prices for the priced products18 Assist in all types of releases required for the company products19 Make recommendations relating to general improvements of the business.20 Attend external meetings/training courses to maintain/improve overall knowledge of regulatoryprocedures, guidelines and directives.21 Complete any other duties as considered necessary by the Company and directed byimmediately Supervisor.
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