۲ ماه پیش
استخدام Regulatory Affairs Expert در شرکت سیناژن
حضوری
سابقه دارد (۱ سال)
حقوق توافقی
تمام وقت
منقضی شده
اطلاعات بیشتر
استخدام شرکت سیناژن
شرکت سیناژن در تهران جهت تکمیل کادر خود به افراد واجد شرایط ذیل نیازمند است.
| Description | job title |
| 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 to obtain and maintain registration through interaction with health authorities Ensuring compliance with regulations set by highly 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 Qualifications: Understanding of both legal and scientific matters Ability to grasp new concepts quickly and to assimilate and evaluate scientific data Time management skills/ the 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 details Well-developed written and oral communication and interpersonal skills/strong negotiation skill Problem-solving skills Team-working skills Presentation skills Integrity and a professional approach to work Having a related background has a positive point (at least 1 year). Excellent computer skills, especially Office Foreign languages: English: fluent in writing/speaking/Listening Other languages have a positive point. |
Regulatory Affairs Expert |
متقاضیان واجد شرایط می توانند با کلیک روی لینک تکمیل فرم استخدام، با انتخاب شغل مورد نظرشان رزومه خود را ارسال نمایند.
اطلاعات تماس
گزارش مشکل آگهی
- ثبت‌نام —
- ایمیل —
- تلفن —
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