EU Labelling

Job Title: EU Labelling & Regulatory Promotional Scientist Type: Contract (12 months) Location: Belgium (remote) Responsibilities: Responsible for European Labelling & Promotional Activities Provide European Labelling & Promotional Regulatory expertise across a Therapeutic business unit. Deliver strategic and operational regulatory input and guidance to the cross functional teams. Creation, update and maintenance of the EU Product Information in line with the CCDS, Agency RTQ, and most up-to-date labelling requirements and labelling template in the appropriate ECMS and according to SOPs If applicable, for assigned Early development assets, deliver competitive labelling searches and contributes to the TCLP Key point of contact for the EU Product Information (Annex I SmPC, Annex II, Annex IIIA Label and Annex IIIB, PIL, IFU) for internal (GRA + strategic Partners in Country) and external stakeholders (medical, legal, commercial, safety, quality and be the EU labelling representative in team meetings (EU RST, Global RST, Product Labeling Team). Lead Reviews, Round Tables, Approvals for the EU Product Information (SmPC, Label, PIL, IFU) in the appropriate system and according to SOP Delivers operational excellence for all labelling activities according to timelines, such as appropriate tracking of the EU Product Information (SmPC, Label, PIL) in the appropriate system and according to SOP Lead the Readability Testing (selection of service provider, management of agreement, review of questionnaire, availability of mock-up, review and submission of final report) Linguistic review process: Lead with the LR Coordinator the Linguistic review according to SOP, assist with the preparation of the Closing Sequence and ensure communication of HA approved label to internal and external stakeholders according to SOP Proactive communication with SPA for Artwork, Mock-up Changes & participates in Changes Control Process as required. Lead the Local Labelling Committee (including but not limited to medical, legal, commercial, safety) for the creation, review and approval for the EU Product Information in the appropriate ECMS and according to SOP. As part of the EU Clearance Committee, primary regulatory reviewer for promotional materials to ensure compliance with applicable codes of conduct, regulations and polices. Ensures validity and appropriateness of content in accordance with the approved EU label and the scientific data to support the safe and effective use by patients. Qualifications: Bachelor's degree in regulatory affairs, life sciences or a related field Experience in labelling and regulatory promotions