استخدام International Regulatory affairs specialist
شرح موقعیت شغلی
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:
Education: Pharmacist, chemist, Biotechnologist, biologist, biochemist
Degree: M.S, Pharm.D, ph.D
Age:25-35
- 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.
مهارتهای مورد نیاز
- Microsoft Office
- تجزیه و تحلیل
- تحلیل و ارزیابی
- تضمین کیفیت
زبانهای مورد نیاز
- انگلیسی
جنسیت
- مهم نیست
وضعیت نظام وظیفه
- مهم نیست