کارشناس رگولاتوری

افق تولید دارو پارس ساوه

منتشر شده 2 سال پیش

سمت شغلی

شرکت

حقوق

آمار رزومه‌های ارسال شده

Job Description

● Studying scientific and legal documents, keeping up to date with changes in regulatory legislation and guidelines. ● Gathering, evaluating, organizing, managing, collating information, and gap analysis in a variety of formats. ● Preparing documents and dossiers for submission/registration dossiers to the Medicine Evaluation Board and supervising the registration procedure in order to obtain and maintain registration through interaction with health authorities. ● Ensuring compliance with regulations set by high regulated agencies (ICH/EMA/FDA/WHO and other international guidelines). ● Planning, undertaking, and overseeing product studies/clinical trials and regulatory inspections. ● Outlining requirements for labeling, storage, and packaging. ● Liaising and negotiating with regulatory authorities. ● Providing advice about regulations to other departments. ● Ensuring that quality standards are met and submissions meet strict deadlines.

Requirements

● Understanding of both legal and scientific matters. ● Ability to grasp new concepts quickly and to assimilate and evaluate scientific data. ● Time management skills. ● Ability to work under pressure and to strict deadlines. ● Excellent organizational and project management skills: coordinate complex activities, often with competing priorities. ● Ability to pay particular attention to detail. ● Well-developed written and oral communication and interpersonal skills. ● Strong negotiation skills. ● Problem-solving skills. ● Team-working skills. ● Presentation skills. ● Integrity and a professional approach to work. ● At least three years of experience. ● Excellent computer skills, especially MS Office.

Employment Type