Description
Regulatory Information Management Business AnalystLocation: Commutable from central London, Hertfordshire, Cambridge and Essex
Salary: Competitive
We are looking for a Regulatory Information Management Business Analyst to be based in their UK office. You can come from a RIM background or be a Regulatory affairs professional looking to move into a more strategic systems technical position.
This is one of the biggest pharmaceutical companies in the UK and a global leader in generics and Branded products.
Position:
The Regulatory Information Management Business Analyst will be the liaison between the business units, information technology and support teams. They will be responsible for project management of various regional and global (new and ongoing) projects within Global Regulatory Operations specifically in the Regulatory Information Management group. The candidate will be required to work across regions and function with staff at all levels to ensure systems are developed to meet the diverse regulatory business needs.
The successful candidate must possess key business analyst skills; should be fluent with the business processes; must leverage deep business or technology expertise to partner with the above functions; understand evolving regulatory guidance; anticipate new user requirements and translate those into project proposals for change. This particular role will involve 10-20% International and domestic travel.
Duties:
- Provide business project management and support the delivery of systems / upgrades and new implementation projects with focus on document management, regulatory data management and submission publishing. Labeling expertise a plus. Including the provision of business consulting support within regulatory functions as appropriate for shared and global solutions.
- Investigate, analyse and document user requirements, including but not limited to requirements definition, solution design, configuration and administration plan.
- Support system validation activities producing sound high quality user acceptance / performance qualification testing scripts and providing review capability for operation qualification scripts.
- Is a contributing member of initiative teams as a representative for GRO.
Must have:
- Bachelor's Degree in Life Sciences or Information Technology.
- Proven experience in Information Technology (SharePoint or other portal technology) or Regulatory experience in a Pharma company.
- Experienced in system and business process design and mapping.
- Working knowledge and understanding of regional regulatory requirements and regulations.
- Experienced with Excel, Microsoft Project, PowerPoint.
- Understanding of the drug development process, generics and branded product development a plus.
- Understanding of planning and risk/mitigation strategies.
- Understanding of SDLC and validation / maintaining validated state and change control methodology a plus.
- Working knowledge of global (FDA, EMA, Health Canada and Japan) regulatory requirements.
This is an excellent role in which a successful Regulatory professional can further their career with a global leader in the pharmaceutical industry!
The Regulatory team ensure that the business is compliant with the pharmaceutical legislation, the licences are granted and updated on time as required and provides the crucial link to the MHRA, which is the UK Regulatory Authority.
The activities of the Regulatory Affairs team stretch across the whole of the UK business, from the implementation to providing support for commercial opportunities, to liaising with the Quality and Artwork Origination teams to ensure variations and packaging updates are submitted for approval by the MHRA to allow us to release our products.
If you are keen to apply please send an updated copy of your C.V and we will contact you with the full company details. Please send your C.V to Natalie Hopkins at n.hopkins(a)realstaffing.com or call