Senior Regulatory Information Management Specialist.

Hertfordshire  ‐ Onsite
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Description

Want your degree in IT to pay off? Read below for more details..

Role:

Life Sciences or Information Technology

Salary:

£50,000

Location:

Hertfordshire

Job Description:
  • Act as the main contact between the business units, information technology and support teams
  • Provide business project management to support the delivery of IT systems / upgrades and new implementation projects with focus on regulatory data management and submission publishing. Includes the provision of business consulting support for regulatory functions as appropriate for shared and global solutions.
  • Work across regions and functions with staff at all levels to ensure regulatory systems are developed and enhanced to meet the diverse regulatory business needs
  • Leverage deep business or technology expertise to partner with the above functions; understand evolving regulatory guidance; understand new user requirements and translate those into project proposals for change
  • Analyse and challenge stated requirements in a professional manner when required to derive actual, clear, or hidden requirements
  • Provide business support for production systems in scope
  • Maintain current knowledge of existing and emerging health authority regulations and programs.


Skills:

You will hold a Bachelor's Degree in Life Sciences or Information Technology (or equivalent). As an ideal candidate you should have extensive experience in Pharmaceutical Regulatory Affairs, particularly in regulatory submissions process (publishing). Knowledge in global regulatory requirements, industry regulatory standards will be required for this role. A solid understanding of the drug development process, generics and branded product development would be a plus.

Call Latifah on alternatively email me on L.khan at realstaffing.com
Start date
12/2015
From
Real Staffing
Published at
01.12.2015
Project ID:
1030069
Contract type
Permanent
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