Hobson Prior currently have an opportunity for a Business Analyst (Regulatory Operations) to join a leading pharmaceutical organisation focused on saving lives all over the world by discovering, developing and offering pioneering products and services. This position will support in Business Analysis activities within Regulatory Affairs Operations with regards to the Article 57 of the EU Regulation 1235/2010 (XEVMPD/IDMP) and the Data Harmonization and Interoperability within Regulatory Affairs.

Job Responsibilities:

• Data Harmonization and Interoperability (incl. IDMP)
• Participation to the global project within Regulatory Affairs and Operations to expand our internal source systems, to become compliant with Article 57 (IDMP in the EU), as well as PQ/CMC in the US. Another objective is to expand the interoperability across these systems, using IDMP as a common language.
• Involvement in the setup of a central group to manage IDMP-related data to support Regulatory Affairs activities in scope of the Application Form, IDMP/SPOR, and other EMA systems.

Key Skills:

• Attention to details, deadlines and quality is key.

Requirements:

• Bachelor degree.
• Background in Regulatory Affairs Operations and/or Information Technology.
• English is required at a fluent level.
• Knowledge of other European languages is very desirable.
• Knowledge of European regulatory environment.
• Pharmacovigilance regulation (Regulation EU 1235/2010) including IDMP and/or XEVMPD.
• Product information (structure of information on medicinal products and substances).
• Knowledge of MS Office tools is a must, especially MS Excel.
  
  Project experience:
• Business analysis and/or project management within large organizations.
• Exchange standards in compliance with international regulations (Information Model).
• Document and records management, content management.
• Online transactional processing systems and tracking systems.
• In relation to the relevance of the project, 5 years in the business domain are required.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.