CMC & Process Excellence Leader
il y a 1 semaine
OverviewJoin a centre of R&D excellence where we work passionately to develop, manufacture and deliver active ingredient solutions for our healthcare partners around the world. You'll ensure we stay ahead of the innovation curve and lead the way in developing sustainably active pharmaceutical ingredients in Europe and beyond, to the highest quality standards.EUROAPI is looking for a hands-on leader to drive CMC and Process Excellence across R&D. You’ll coordinate efforts across Small Molecules, Tides, and Biotechnology teams, support regulatory deliverables, and help build a strong knowledge-sharing culture. You’ll also lead initiatives to improve how teams work, train newcomers, and define smart data strategies for regulatory submissions.Key ResponsibilitiesLeadership & StrategyReport to the Chief R&D Officer and is part of the R&D Leadership Team.In close collaboration with the Head of Innovation and the platform leaders, impulse and lead the newly integrated CMC and Process Excellence structureClarify roles and improve support for regulatory submissionsCoordination & CollaborationLead expert groups in key topics such as chemical or biochemical synthesis, process development, analytics, and regulatory affairsAlign quality and regulatory strategies with cross-functional teamsGuide working groups to define and improve ways of workingTraining & StandardsIdentify skill gaps and roll out targeted trainingCreate clear, practical training materials and templatesStandardize onboarding for newcomersDefine acceptable risk levels to avoid unnecessary data collectionCommunity & Knowledge SharingAssess and enhance expert communities to ensure alignment with CMC objectivesIdentify qualified participants and implement a clear nomination process, while setting appropriate meeting frequencies to drive active engagementPromote best practices and continuous learningBuild a knowledge management system to capture and share regulatory insightsKey SkillsClear communication and ability to simplify complex topicsEmpowering leadership and change managementStrategic thinking and systems mindsetStrong collaboration and stakeholder alignmentAnalytical and problem-solving mindsetCuriosity and openness to innovationQualificationsAdvanced degree in Chemistry, Pharmaceutical Sciences, or related fieldExperience in CMC, R&D, and process developmentStrong leadership and change management skillsExperience in regulatory affairs, training programs, or scientific communication is a plus.Familiarity with knowledge management and AI tools is desirableOur companyEUROAPI is focused on reinventing active ingredient solutions to sustainably meet customers’ and patients’ needs around the world. We are a leading player in active pharmaceutical ingredients with approximately 200 products in our portfolio, offering a large span of technologies, while developing innovative molecules through our Contract Development and Manufacturing Organization (CDMO) activities.Taking action for health by enabling access to essential therapies inspires our 3,450 people every day. With strong research and development capabilities and six manufacturing sites all located in Europe (Saint-Aubin-lès-Elbeuf and Vertolaye in France, Brindisi in Italy, Frankfurt in Germany, Budapest in Hungary and Haverhill in the UK), EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.EUROAPI is listed on Euronext Paris.Culture & Values at EuroapiWe bring our culture to life in the way we work every day. Our culture allows career development and talent management, we recognise that how we do things is as important as what we do, and our values define how we achieve our goals and help us to “do things right”.Our values and behaviours are based on the following pillars :We empower our people to have a greater positive impact.We create value by placing our customers at the centre of everything we do.We take responsibility for what we do, always acting in the best interests of the company.We value and respect all our stakeholders.EUROAPI is committed to a culture of diversity and inclusion that contributes to improved innovation, performance and engagement.Nous valorisons la transparence, le respect mutuel et l'égalité de traitement des personnes. C'est pourquoi nous protégeons fermement nos employés contre toute forme de discrimination.We are convinced that the success of our company lies in its ability to adapt to the challenges of tomorrow. Our responsibility as a company is to ensure the sustainability and resilience of the pharmaceutical value chain. #J-18808-Ljbffr
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Senior Manager CMC Regulatory
il y a 1 semaine
Paris, France Ipsen Pharma (SAS) Temps pleinTitle: Senior Manager CMC Regulatory Company: Ipsen Innovation (SAS) About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we...
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Senior Manager CMC Regulatory
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Paris, Île-de-France Ipsen Temps pleinPOSITIONJob TitleSenior Manager, CMC Regulatory Strategy BiologicsDivision / FunctionGlobal Regulatory Affairs (GRA)Manager's Job TitleDirector/Sr Director CMC Regulatory Strategy BiologicsIpsen Job ProfileRegulatory CMCLocation:Paris, FR & Paddington, UKWHAT - Summary & Purpose Of The PositionResponsibility for CMC regulatory strategy for the assigned...
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Senior Manager CMC Regulatory
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il y a 1 semaine
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Biologics CMC Regulatory Strategy Lead
il y a 6 jours
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Senior Manager CMC Regulatory
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