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Job Details

Regulatory Affairs Assistant, Bulgaria-143794

Company: PPD
Location: Europe, Middle East & Africa-Bulgaria-Sofia-Sofia
Reference: 143794
Closing Date: 22 Mar 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. ...

Requirements:

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.

With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health.

 

For more information, visit www.ppdi.com.


Now a great opportunity exists for University graduates to join our Regulatory Affairs team in Sofia at the position of

Regulatory Affairs Assistant
 
Responsibilities:
 
•    Provides  regulatory support to Regulatory Specialists and internal PPD Project team  in  preparation, planning and coordination of regulatory documentation from provision from a client to timely submission of final document back to client or relevant Regulatory Authorities;
•    Maintains tracking  and status update of  project in PPD and/or client databases;
•    Keeps colleagues and/or client informed of delayed, missing or incomplete items; ensure follow-up and completion of all transactions are performed in a timely manner.

Qualifications

Education and Experience:
 
•    University degree. Bachelor  degree in science - related field is an advantage;
•    Previous experience working in the pharmaceutical/ CRO industry is an advantage;
   
Knowledge, Skills, abilities

•    General knowledge of global/ regional/ national country requirements/ Regulatory Affairs Procedures for Clinical Trial Authorization is an asset;
•    Very good English language skills;
•    Ability to read, analyze and interpret general and business periodicals, study documents, technical procedures or governmental regulations, to write reports, business correspondence and procedure manuals, and to effectively present information and respond to questions from wide range of internal and external stakeholders;
•    Computer skills (Microsoft office) and experience in applications used in clinical trials (eTMF, CTMS) would be an advantage;
•    Good organizational and planning skills;
•     Ability for multiple project tasking;
•    Proven ability to work effectively in a team environment.


HOW TO APPLY:
 
Please submit your CV in English.
 

Apply for this job: Regulatory Affairs Assistant, Bulgaria-143794

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Website:  Visit Our Web Site

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