REGULATORY AFFAIRS ASSOCIATE

BrusselIFarmaceutische industrie

Functieomschrijving

For one of our pharma clients in Brussels we're looking for a REGULATORY AFFAIRS ASSOCIATE.

As Regulatory Affairs Associate you will cover the business analysis activities to fulfill 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. Your close contacts will be with the IDMP Global Business Lead, the IDMP Regional Business Lead, the XEVMPD Data Stewards, the Regulatory Affairs department, departments within HQ (CMC, IT…), and the European Authorities.

As Regulatory Affairs Associate your primary activities include:
  • 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)
  • XEVMPD Enhancements
    • Participation to the enhancements of the XEVMPD solution at MSD based on Liquent Insight (although rather stable since March 2020), and the support to the Falsified Medicines Directive in Europe.
Profiel

As REGULATORY AFFAIRS ASSOCIATE your profile matches the following description:

  • You have a bachelor degree with a background in Regulatory Affairs Operations and/or Information Technology
  • Ideally, you have about 5 years' experience in the business domain
  • You are fluent in English, knowledge of other European languages is desirable
  • You have 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)
  • You possess experience with Pharmacovigilance regulation (Regulation EU 1235/2010) including IDMP and/or XEVMPD
  • Relating to project working, you have experience with business analysis and/or project management with large organizations
  • You are familiair with standards in compliance with international regulations (Information Model)
  • You have knowledge of MS Office (especially MS Excel), Liquent Insight for Registrations, Document Management Systems (e.g. Documentum-based systems), XEVMPD tools (e.g. EV Web)
Organisatie- en afdelingomschrijving

Select Projects is part of the Select group, a collection of HR companies that put people first because Quality is Performance by Genuine People. Select Projects provides technical support to clients on a project basis. Our 220 employees in Belgium and the Netherlands support companies with their projects in various domains: Life Sciences, (petro) chemical, Construction and Rail. From our offices in Antwerp and Rotterdam we optimally support our experienced specialists so that they can deliver high quality to our customers at all times.

Aanbod

You get an attractive salary package with interesting fringe benefits. A company car, meal vouchers, group insurance and mobile phone subscription are possible. We ensure that you end up in a pleasant working environment with nice colleagues and opportunities to develop and further develop. Together with you, we map out a training course tailored to your future plans and needs.

Heb je nog vragen?
Marlies Collart Human capital developer Select Projects +32 3 203 50 80
REGULATORY AFFAIRS ASSOCIATE Vacature informatie
77137
Techniek - projecten
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