Regulatory Affairs Manager/Senior Manager – CMC
h3Work Schedule /h3 pStandard (Mon-Fri) /p h3Environmental Conditions /h3 pOffice /p h3Job Description /h3 pJoin our global Regulatory Affairs team in a client-dedicated role supporting commercial medicinal products used in clinical trials, including comparator and auxiliary medicinal products. /p pThis highly client-facing position combines bEU/EEA regulatory assessment, CMC and labelling expertise, regulatory change control, Summary of Changes preparation, regulatory intelligence and cross-functional coordination /b . /p pStrong CMC expertise is essential; however, the primary focus is broader than CMC authoring. The role will assess proposed changes, determine regulatory impact, coordinate implementation activities and support the development of effective processes and ways of working. /p h3What You'll Do /h3 ul lipPerform bEU/EEA regulatory assessments of changes /b , applying applicable legislation, EU Clinical Trials Regulation requirements and regulatory guidance. /p /li lipAssess the impact of CMC, manufacturing, supply and labelling changes on clinical trial documentation and determine appropriate regulatory actions, including substantiality assessments where applicable. /p /li lipPrepare and maintain bSummary of Changes (SoC) /b documentation. /p /li lipManage: /p /li lipbProduct-specific changes /b impacting sIMPDs, SmPCs and clinical labels. /p /li lipbNon-product-specific changes /b impacting manufacturing/release site lists, manufacturing licences and GMP certificates. /p /li lipReview and compare revised SmPCs, clinical labels, manufacturing licences, GMP certificates and related documents to identify and assess relevant changes. /p /li lipProvide CMC regulatory expertise and support targeted authoring, updating or expert review of bsIMPD and other CMC documentation when required /b .
/p /li lipCoordinate regulatory bchange-control activities /b , including planning, stakeholder coordination, action follow-up and maintenance of trackers and systems. /p /li lipProvide regulatory intelligence and practical interpretation of EU/EEA requirements in response to client and cross-functional questions. /p /li lipWork closely with Regulatory Affairs, CMC, Labelling, Quality Assurance and Clinical Supplies teams to identify regulatory implications, dependencies and required actions. /p /li lipProactively identify issues, propose pragmatic solutions and ensure activities progress within agreed timelines. /p /li lipSupport the development and continuous improvement of bprocesses, templates, trackers, decision frameworks and ways of working /b . /p /li lipEnsure activities and deliverables meet applicable regulatory, quality and organizational requirements. /p /li /ul h3Education and Experience Requirements /h3 ul lipBachelor's degree or equivalent in a relevant scientific discipline; Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences or related disciplines preferred. /p /li lipb8+ years of directly relevant Regulatory Affairs experience /b , with a strong CMC background. /p /li lipStrong experience with EU/EEA clinical trial regulatory requirements and CMC regulatory documentation. /p /li lipPractical experience performing bregulatory change assessments /b ,
including assessing the impact of CMC, manufacturing, supply or labelling changes. /p /li lipExperience determining whether changes require substantial or non-substantial modification under applicable EU clinical trial requirements. /p /li lipExperience supporting bEU Clinical Trials Regulation submissions /b . /p /li lipStrong CMC authoring and review expertise, including experience with bsimplified IMPDs or comparable CMC documentation /b . /p /li lipExperience with pharmaceutical manufacturing, commercial medicinal products, clinical supplies and/or quality documentation preferred. /p /li lipExperience working directly with clients and coordinating activities across multiple functions and stakeholders preferred. /p /li /ul pEquivalent combinations of education, training and directly related experience may also be considered. /p h3Knowledge, Skills and Abilities /h3 ul lipStrong knowledge of bEU/EEA clinical trial and CMC regulatory requirements /b . /p /li lipAbility to interpret regulatory requirements and translate them into clear, practical and defensible regulatory assessments. /p /li lipStrong analytical skills and ability to compare complex documentation and identify regulatory impact. /p /li lipExcellent borganizational, planning and change-management skills /b , with the ability to manage multiple activities and dependencies concurrently. /p /li lipStrong bprocess-oriented mindset /b , with the ability to bring structure to evolving activities and define effective ways of working. /p /li lipExcellent client and stakeholder management skills, including bpatience, resilience and professionalism /b . /p /li lipProactive approach with the ability to work independently, exercise sound judgement and drive activities to complet
/p /li lipCoordinate regulatory bchange-control activities /b , including planning, stakeholder coordination, action follow-up and maintenance of trackers and systems. /p /li lipProvide regulatory intelligence and practical interpretation of EU/EEA requirements in response to client and cross-functional questions. /p /li lipWork closely with Regulatory Affairs, CMC, Labelling, Quality Assurance and Clinical Supplies teams to identify regulatory implications, dependencies and required actions. /p /li lipProactively identify issues, propose pragmatic solutions and ensure activities progress within agreed timelines. /p /li lipSupport the development and continuous improvement of bprocesses, templates, trackers, decision frameworks and ways of working /b . /p /li lipEnsure activities and deliverables meet applicable regulatory, quality and organizational requirements. /p /li /ul h3Education and Experience Requirements /h3 ul lipBachelor's degree or equivalent in a relevant scientific discipline; Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences or related disciplines preferred. /p /li lipb8+ years of directly relevant Regulatory Affairs experience /b , with a strong CMC background. /p /li lipStrong experience with EU/EEA clinical trial regulatory requirements and CMC regulatory documentation. /p /li lipPractical experience performing bregulatory change assessments /b ,
including assessing the impact of CMC, manufacturing, supply or labelling changes. /p /li lipExperience determining whether changes require substantial or non-substantial modification under applicable EU clinical trial requirements. /p /li lipExperience supporting bEU Clinical Trials Regulation submissions /b . /p /li lipStrong CMC authoring and review expertise, including experience with bsimplified IMPDs or comparable CMC documentation /b . /p /li lipExperience with pharmaceutical manufacturing, commercial medicinal products, clinical supplies and/or quality documentation preferred. /p /li lipExperience working directly with clients and coordinating activities across multiple functions and stakeholders preferred. /p /li /ul pEquivalent combinations of education, training and directly related experience may also be considered. /p h3Knowledge, Skills and Abilities /h3 ul lipStrong knowledge of bEU/EEA clinical trial and CMC regulatory requirements /b . /p /li lipAbility to interpret regulatory requirements and translate them into clear, practical and defensible regulatory assessments. /p /li lipStrong analytical skills and ability to compare complex documentation and identify regulatory impact. /p /li lipExcellent borganizational, planning and change-management skills /b , with the ability to manage multiple activities and dependencies concurrently. /p /li lipStrong bprocess-oriented mindset /b , with the ability to bring structure to evolving activities and define effective ways of working. /p /li lipExcellent client and stakeholder management skills, including bpatience, resilience and professionalism /b . /p /li lipProactive approach with the ability to work independently, exercise sound judgement and drive activities to complet