الوصف الوظيفي
Coordinate and document Internal regulatory process such as internal audit and licence renewal. prepare material submission to regulatory agencies .studying scientific and legal documents
gathering, evaluating, organizing, managing and collating information in a variety of formats
ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA)
maintaining familiarity with company product ranges
planning, undertaking and overseeing product trials and regulatory inspections
keeping up to date with changes in regulatory legislation and guidelines
analyzing complicated information, including trial data
offering advice about company policies, practices and systems
obtaining marketing permission
outlining requirements for labeling, storage and packaging
using a variety of specialist computer applications
liaising and negotiating with regulatory authorities
providing advice about regulations to manufacturers/scientists
writing comprehensible, user-friendly, clear product information leaflets and labels
ensuring that quality standards are met and submissions meet strict deadlines
preparing documentation.
المهارات
Law and Government - Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Medicine and Dentistry - Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
Administration and Management - Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
Biology - Knowledge of plant and animal organisms, their tissues, cells, functions, inter dependencies, and interactions with each other and the environment.
Clerical - Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
Education and Training - Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.
Chemistry - Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo. This includes uses of chemicals and their interactions, danger signs, production techniques, and disposal methods.
Computers and Electronics - Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
Customer and Personal Service - Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
Mathematics - Knowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.
Production and Processing - Knowledge of raw materials, production processes, quality control, costs, and other techniques for maximizing the effective manufacture and distribution of goods.
Personnel and Human Resources - Knowledge of principles and procedures for personnel recruitment, selection, training, compensation and benefits, labor relations and negotiation, and personnel information systems.
Communications and Media - Knowledge of media production, communication, and dissemination techniques and methods. This includes alternative ways to inform and entertain via written, oral, and visual media.
Public Safety and Security - Knowledge of relevant equipment, policies, procedures, and strategies to promote effective local, state, or national security operations for the protection of people, data, property, and institutions.
Psychology - Knowledge of human behavior and performance; individual differences in ability, personality, and interests; learning and motivation; psychological research methods; and the assessment and treatment of behavioral and affective disorders.
Sales and Marketing - Knowledge of principles and methods for showing, promoting, and selling products or services. This includes marketing strategy and tactics, product demonstration, sales techniques, and sales control systems.
Work Styles
تفاصيل الوظيفة
منطقة الوظيفة جدة, المملكة العربية السعودية
قطاع الشركة الطبي/المستشفيات
طبيعة عمل الشركة صاحب عمل (القطاع الخاص)
الدور الوظيفي المشتريات
نوع التوظيف دوام كامل
الراتب الشهري $1,500 - $2,000
عدد الوظائف الشاغرة 1
المرشح المفضل
المستوى المهني مبتدئ الخبرة
عدد سنوات الخبرة الحد الأدنى: 3 الحد الأقصى: 6
منطقة الإقامة المملكة العربية السعودية
الجنس ذكر
الشهادة ماجستير
العمر الحد الأدنى: 26 الحد الأقصى: 36
التعليم
MBA, Msc or Bsc (Must Have 5 Years Experience in SFDA
*** تقدم على الرابط التالي : Apply on the following link ***
https://www.bayt.com/ar/saudi-arabia/jobs/regulatory-affairs-manager-sfda-3915679/