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استخدام International Regulatory affairs specialist در سیناژن

(4 weeks ago)

کارفرما • تهران، تهران

نوع همکاری

تمام وقت

سفرهای کاری

—

شاخص‌های کلیدی از نظر کارفرما

دیپلم

شرح شغل و وظایف

استخدام سیناژن

سیناژن در تهران جهت تکمیل کادر خود به افراد واجد شرایط ذیل نیازمند است.

Description

job title

Gender: any
From 25 to 35
Having related background has a positive point (at least 1 year).
Job Description
Key duties:
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 heath 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 labelling, 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
Excellent computer skills, specially Office
Foreign languages:
English: fluent in writing/speaking/listening
*Other languages have a positive point.

International Regulatory affairs specialist

متقاضیان واجد شرایط می توانند با کلیک روی لینک تکمیل فرم استخدام، رزومه خود را ارسال نمایند.

شرایط احراز شغل

سن

18 - 50 سال

جنسیت

فرق نمی کند

تحصیلات

دیپلم

استخدام نیرو انسانی — کلیک کنید

ارسال رزومه برای کارفرما

مشاهده

موقعیت شغلی

استخدام International Regulatory affairs specialist در سیناژن

استخدام نیرو انسانی — کلیک کنید