شرکت تحقیقاتی و تولیدی سیناژن
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International Regulatory affairs specialist(584 days ago)
اشتراک گذاری
Tehran/ Shahrak Gharb
Full Time
8:30-17:30
-
Loan -Bonus -Health insurance -Lunch -In-house Medical doctor -Library
501 - 1000 employees
Pharmaceutical
Iranian company dealing with Iranian and foreign customers
1373
Privately held
توضیحات بیشتر angle

key Requirements

1 years experience in similar position
Master Chemistry or Biotechnology or Biology / Life Sciences/ Lab Sciences / PhD Pharmacy/Pharmacology
language English-Advanced

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
  • Having related background has a positive point (at least 1 year).
  • Excellent computer skills, specially Office

Foreign languages: 
English: fluent in writing/spiking/listening
*Other languages has a positive point.

Job Requirements

Age
25 - 35 Years Old
Gender
Men / Women
Military service
Military service must be done
Education
PhD| Pharmacy/Pharmacology Master| Chemistry Master| Biotechnology Master| Biology / Life Sciences/ Lab Sciences
Language
English| Advanced 90%
Software
Microsoft Word| Advanced Microsoft Outlook| Advanced Microsoft Powerpoint| Advanced Microsoft Excel| Advanced

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