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Regulatory Affairs Specialist
Это объявление было просмотрено
Компания: FMD K&L
Локация: Yerevan, Армения
Длительность: Long-term
Дата начала: ASAP
Крайний срок: 10 January 2020

ОПИСАНИЕ ДОЛЖНОСТИ: 

FMD K&L Armenia is seeking an enthusiastic specialist with life science appropriate background for the position of Regulatory Affairs Specialist. The incumbent will become a member of one of the biggest CROs worldwide. The Regulatory Affairs Specialist is directed by the Head of Regulatory Affairs Department.

ОБЯЗАННОСТИ: 

- Take responsibility for assigned tasks and/ or projects;
- Ensure compliance within the Department by ensuring global, regional and local processes, policies, SOPs and working instructions are adhered to;
- Update relevant global, regional and local databases to ensure compliance;
- Review artwork and promotional copy material to ensure regulatory compliance with local regulations;
- Use available electronic publishing tools to compile, electronic or paper based submissions necessary to meet regulatory requirements;
- Maintain and archive regulatory documentation, as appropriate;
- Organize and maintain reporting schedules;
- Assist with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides;
- Conduct searches of existing files for requested information;
- Ensure quality and compliance in all actions;
- Execute other job-related duties under direction of an expert or manager.

ТРЕБУЕМАЯ КВАЛИФИКАЦИЯ: 

- Higher education in Life Sciences (Pharmacology, Chemistry, Biology, Medicine);
- At least 2 years of experience as a Regulatory Affairs Specialist;
- Knowledge and understanding of drug regulations;
- Fluency in English language, both written and spoken;
- Ability to work under pressure to meet deadlines;
- Task-orientation;
- Ability to get a challenge and perform excellent teamwork;
- Specialized knowledge level, with sufficient experience and skill to execute under general supervision.

ПРОЦЕДУРА ПОДАЧИ ЗАЯВОК: 

Interested candidates are welcome to send their CV to: ***.**@******.*** indicating the position title ("Regulatory Affairs Specialist") in the subject line of the email. Please note that only shortlisted candidates will be contacted.

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ОТКРЫТ ДЛЯ/ КРИТЕРИИ ОТБОРА: 

All interested candidates

О КОМПАНИИ: 

FMD K&L is a global contract research organization (CRO) offering a full range of ICH GCP compliant clinical research services for multinational pharmaceutical and medical device companies looking to establish their medical product(s) in the US, Europe, and parts of East Asia (including China, Hong Kong, Taiwan and South Korea).