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Regulatory Affairs Specialist
| 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.Пожалуйста, четко укажите в своем заявлении, что вы узнали об этой возможности через Career Center, и укажите URL-адрес нашего веб-сайта - www.careercenter.am. Спасибо.
