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Regulatory cmc scientist

Bruxelles
Ucb Pharma
Publiée le 12 mai
Description de l'offre

PpWe are looking for a Regulatory CMC Scientist to join our Global Regulatory team, based in any of our Brussels (Belgium) or Slough (UK) offices. /p h3About The Role /h3 pDefine the strategy, planning and preparation (writing and review) of CMC submission documentation for regulatory submissions (new marketing applications, variations) from a global/regional perspective to achieve timely approvals to meet business needs. /p h3Who You’ll Work With /h3 pYou will work within the Regulatory CMC team and partner with other technical and regulatory functions across the business. /p h3What You’ll Do /h3 ul liResponsible for regional and global CMC submissions in line with agreed global regulatory strategy, and within agreed timelines. /li liContribute and ensure adequate provision of regulatory CMC input to all Health Authority (HA) interactions on CMC matters in all regions /li liEnsures effective communication of CMC regulatory strategy, risks, and overall plan to GRA Teams, Technical, Development and Commercial Teams /li liHighlights anticipated and ongoing critical issues arising through the product life cycle in a timely manner to senior management to enable communication to key stakeholders /li liLead or contribute to ongoing process improvement and department initiatives within the CMC Regulatory Affairs function, including process improvements, SOP review and development, and evaluation/implementation of digital strategies and tools. /li /ul h3Qualifications /h3 ul liBachelor’s degree, Master’s preferred in a relevant life science or business-related discipline /li liDemonstrated ability to leverage digital tools, structured data, and regulatory information systems to enhance CMC and Device regulatory strategy, submission quality, lifecycle management, and decision‑making across global markets /li liSignificant relevant experience in the pharmaceutical industry preferably in Regulatory Affairs CMC with focus on chemical entities /li liProven track record of successful authoring and contribution to delivering CMC sections of marketing authorisations for new chemical entities /li liKnowledge of GMP requirements, standard systems (e.g. change management systems and tools) /li liEffective interpersonal, presentation and communication skills with established internal and external stakeholders /li /ul pWe would love to hear from you if this sounds like you! /p pUCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws. /p pShould you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us on Please note if your enquiry does not relate to adjustments, we will not be able to support you through this channel. /p /p #J-18808-Ljbffr

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