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Job Details

Junior Regulatory Affairs Associate

Company: PAREXEL
Location: Bucharest, Bucure?ti,Romania
Reference: 41548BR
Closing Date: 25 Mar 18
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

The Junior Associate assists in the production of submissions and delivery of regulatory services in accordance with defined agency guidelines while balancing the quality and timeliness of customer deliverables. ...

Requirements:

The Junior Associate assists in the production of submissions and delivery of regulatory services in accordance with defined agency guidelines while balancing the quality and timeliness of customer deliverables.


Scope of responsibilities:

• Supporting trial master file (TMF) shipment activities and TMF reconciliation
• Working under the general direction of the Regulatory Manager/Project Manager, taking responsibility for ensuring that the client work is performed and delivered on time
• Maintain a working knowledge of, and ensure compliance with, applicable ICH Guidelines, GCP, Regulatory Agency requirements and internal SOPs
• May prepare and/ or deliver presentation with the support of senior colleagues
Qualifications
Ideal candidate will possess:

• Previous regulatory experience with Clinical Trials in Pharma/CRO will be an asset
• Fluency in English and Romanian
• A degree in Life Sciences. Advanced degree desirable
• Ability to work with a multinational team, focusing on multiple issues under tight timelines
• Good computer skills

Apply for this job: Junior Regulatory Affairs Associate

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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