New-Gen


Functional Experience: Consulting Services; Logistics, Transport Industry Experience: Biotech, Health Science, Pharma.; Biotech, Health Science, Pharma.
Job: 003599	Archiving and Registration Compliance - Berkshire \| 2010-02-25
Company:	NonStop _Recruitment
Country:	United Kingdom
State:	Londonderry
City:
Professional Level:	Analyst/Consultant
Employment Type:	Full-time / Permanent
Compensation Level:	35000 per Year United Kingdom, Berkshire, 25000.00 - 35000.00 United Kingdom Pounds/Year
Choice of how resumes arrive:	Microsoft Word Microsoft Excel
Job
# Description Registration Compliance Analyst - Archiving, Documentum & Liquent Join one of the worlds leading healthcare company with a core focus on a vast range of therapeutic areas. Offering one of the best benefits scheme in the industry, this is an attractive option. This role will incorporate usuage of documentum and liquent to enter data and archiving You will set up and maintain a Pharmaceutical Products Group registration tracking database that houses regulatory approval data. Tracking of EU product registrations, including all regulatory correspondence and submissions, for regulatory planning and strategic planning purposes, as part of a team. Registration tracking database. and entry into the database of up-to-date EU regulatory correspondence documentation and EU regulatory submissions (e.g. Centralized Process, Mutual Recognition Process and Clinical Trials Applications). Understanding of the EU and CTA submission processes and related correspondence documentation. The incumbent will leverage the database to track the regulatory submission and approval progress using a standardized, peer-reviewed process.
Required Skills & Experience EXPERIENCE Regulatory Affairs / Regulatory Submission Operations or related Business Processes experience Documentum and Archiving experience. Prefered Experience in the registration and maintenance of pharmaceutical products in European markets. General knowledge of regulatory affairs functions, including Submissions, CMC, Labeling and Operations. Prior experience in working within any regulatory system database is preferred. Prior experience with electronic systems (for example, global document management or electronic publishing) is also preferred. Must have good communication skills and be able to juggle multiple and competing priorities. Familiarity with PC and software packages such as Word, Excel and Lotus Notes. Experience with registration tracking is a plus. For more information regarding this vacancy please contact Abid Kanji on 0207 940 2108 or email him at a.kanji@nonstop-pharma.com
Pre-application questions: NO