For a client in Brussels we are looking for a Support in Business Analysis activities within Regulatory Affairs Operations'.You will be responsible for the 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
The mission covers business analysis activities to fulfil the Article 57 requirements that fall under the EU Regulation 1235/2010, also known as XEVMPD (Extended EudraVigilance Medicinal Product Dictionary) and IDMP (Identification of Medicinal Products) in Europe.
Primary activities include, but are not limited to:
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.
- Participation to 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.
IDMP Data Remediation
- Coordination of activities to prepare and collect information included in scope of IDMP Iteration 1 in Europe, in close collaboration with European affiliates and a number of departments (e.g. CMC)
- Activities cover coordination, pilot, documentation, training, support, and follow-up
IDMP To-Be Processes
- Participation to the definition of to-be IDMP processes, covering essentially the European regulatory aspects, possibly extended to other countries (e.g. Switzerland)
- Participation to the adaptation of internal processes and systems to the replacement of Electronic Application Forms in the EU (CESSP Project).
The mission will be conducted in close relationship with the IDMP Global Business Lead (US-based), the IDMP Regional Business Lead (Brussels-based), the XEVMPD Data Stewards, the Regulatory Affairs department (Regional Center and Affiliates), departments within HQ (CMC, IT…), and the European Authorities.
- Participation to the enhancements of the XEVMPD solution at our client based on Liquent Insight (although rather stable since March 2020), and the support to the Falsified Medicines Directive in Europe.
- 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
- Attention to details, deadlines and quality is key
Relevant business experience is desirable in the following domains:
- Knowledge of European regulatory environment including all marketing authorization types (Centralized, Mutual Recognition, Decentralized and National Procedures), Initial Marketing Applications and Post-Approval Procedures, eCTD (Electronic Common Technical Document), Electronic Application Form (eAF), Regulatory Information Management systems (RIM)
- Pharmacovigilance regulation (Regulation EU 1235/2010) including IDMP and/or XEVMPD
- Product information (structure of information on medicinal products and substances)
- Experience in multicultural organizations
- 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
- Knowledge of MS Office tools is a must, especially MS Excel
- Knowledge of Liquent Insight for Registrations is a plus
- Knowledge of Document Management Systems (e.g. Documentum-based systems) is a plus
- Knowledge of XEVMPD Tools (e.g. EV Web) is a plus