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Regulatory Affairs Officer

5.00 to 15.00 Years   Al Kuwait, Kuwait   19 Jul, 2019
Confidential Company
1 Jobs Openings
Job LocationAl Kuwait, Kuwait
EducationBachelor's degree / higher diploma
SalaryNot Mentioned
IndustryHealthcare, other; Pharmaceutical
Functional AreaNot Mentioned

Job Description

The Regulatory Affairs Officer is responsible to provide input as required at all levels within the company. The main responsibility is to plan and execute all activities necessary for the registration of new products and line extension indications. The Regulatory Affairs Officer ensures the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products.ESSENTIAL DUTIES:1 Ensuring that a companys products comply with the regulations of the Medicines and Healthcare products Regulatory Agency (MHRA).3.?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 companys product range.5 Developing and writing clear point of view and explanations for new product license and licenses renewals.6 Preparing submissions of license variations and renewals; setting timelines for license variations and 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 clinical trials 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 regulatory authorities on a regular basis.14 Review of validation, development and stability reports to ensure compliance with licence details and 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 of regulatory support.17 Make recommendations relating to general improvements of the business.18 Attend external meetings/training courses to maintain/improve overall knowledge of regulatory procedures, guidelines and directives.19 Maintain complete confidentially of the company business.20 Complete any other duties as considered necessary by the Company and directed by immediately Supervisor.

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