JOB DESCRIPTION
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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.
RESPONSIBILITIES
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- 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.
REQUIRED QUALIFICATIONS
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- 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.
APPLICATION PROCEDURES
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Interested candidates are welcome to send their CV to:
arm.hr@klserv.com indicating the position title ("Regulatory Affairs Specialist") in the subject line of the email. Please note that only shortlisted candidates will be contacted.
Please clearly mention in your application letter that you learned of this job opportunity through Career Center and mention the URL of its website - www.careercenter.am, Thanks.
OPEN TO/ ELIGIBILITY CRITERIA
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All interested candidates