Regulatory Affairs Senior Associate, Central
Il y a 2 mois
locations- Zaventem- time type- Full time- posted on- Posted Today- job requisition id- JR00014179- Zoetis Belgium is looking for a Regulatory Affairs Senior Associate to support the provision of registration dossiers to our in-country regulatory colleagues for submission to national regulatory authorities throughout the Central & Eastern Europe, Africa and Middle East (EEMA) region.
- Role Purpose
- The overarching objective of the EEMA regional Regulatory Affairs and Affiliate Quality team is to help our Commercial colleagues achieve their revenue and growth targets by providing regulatory and quality oversight and guidance, and dossiers for new market introductions (Geographic Expansion).
- The Regulatory Affairs Senior Associate will be part of a small team acting as a bridge between our Research and Development (R&D) and International Operations (Commercial) divisions, ensuring that registration dossiers meet market-specific needs and are delivered according to the agreed schedule.
- Responsibilities
- Operation of the Geographic Expansion Process for EEMA, including, but not limited to:
- Ensuring understanding of, and adherence to process steps and timelines by all stakeholders
- Provision of regulatory documents to markets, in accordance with their needs and the agreed timelines
- Dossier review and/or compilation, as required
- Archiving of regulatory documents, submissions, queries, approvals, and correspondence, in accordance with VMRD requirements
- Operation of the Geographic Expansion Wish List, Assessment and Tracking system, including, but not limited to:
- Ensuring completeness and accuracy of entries
- Reporting of metrics and key performance indicators
- Maintenance and further development of the system
- Participation in ad hoc projects
- Use of global systems and tools to respond to queries and generate status reports, including, but not limited to:
- Trackwise ETS (registration database and change control)
- SAP (product labelling and trade compliance modules)
- Veeva Vault (document archive)
- SharePoint
- Business Objects & Power BI
- Profile
- Veterinary, Pharmacy, or other chemistry or life sciences degree
- At least 2 years’ experience of the pharmaceutical industry (human health or animal health)
- Knowledge of EU and/or US legislation and guidance would be an advantage
- Demonstrated competence in MS Word, Excel and PowerPoint
- Experience of SAP, Veeva Vault and Trackwise ETS or similar systems would be an advantage
- Highly organized, methodical with good attention to detail
- Ability to multi-task and to work to demanding timelines
- Excellent communication skills (written and spoken) in English
- This position is based in the Zoetis office in Zaventem
Full time
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