[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"project-cmc-regulatory-expert-mwd-fokus-peptid-parenterale-originalpraeparate-2":3,"similar-cmc-regulatory-expert-mwd-fokus-peptid-parenterale-originalpraeparate-2":30},{"id":4,"slug":5,"title":6,"skills":7,"budget":16,"duration":17,"location":16,"onsitePercent":18,"contractType":19,"foundAt":20,"category":21,"description":25,"rawText":26,"language":27,"projectId":28,"sourceUrl":29},5005,"cmc-regulatory-expert-mwd-fokus-peptid-parenterale-originalpraeparate-2","CMC Regulatory Expert (m\u002Fw\u002Fd) – Fokus Peptid \u002F parenterale Originalpräparate",[8,9,10,11,12,13,14,15],"CMC-Dokumentation","Originalpräparate","parenterale Peptid-Produkte","Modul 3 (Quality)","Regulatory Affairs","EMA\u002FFDA Anforderungen","Dossier-Erstellung","Manufacturing Change Control",null,"bis mindestens 31.12.2026 (Option auf Verlängerung)",50,"contracting","2026-05-21T08:16:18+00:00",{"id":22,"slug":23,"label":24},14,"medical_tech","Medizintechnik","Spezialisierte externe Unterstützung im Bereich CMC-Dokumentation für Originalpräparate. Fokus auf hochkomplexen parenteralen Peptid-Produkten mit eigenständiger Dossier-Erstellung. Enge Abstimmung mit internen Regulatory Affairs Experten.","CMC Regulatory Expert (m\u002Fw\u002Fd) – Fokus Peptid \u002F parenterale Originalpräparate\n\nJob ID:\n3087\nJetzt loslegen\n\nOrt\n\nempty-city\n\nRahmendaten\n\n\u003Ch3>\u003Cstrong>Projektkontext\u003C\u002Fstrong>\u003C\u002Fh3> \u003Cp>Für unseren Pharma-Kunden suchen wir spezialisierte externe Unterstützung im Bereich \u003Cstrong>CMC-Dokumentation für Originalpräparate\u003C\u002Fstrong>.\u003C\u002Fp> \u003Cp>Im Zuge einer organisatorischen Neuausrichtung und steigender regulatorischer Komplexität wird gezielt Expertise benötigt, die über klassische Pharma-Dokumentationsdienstleister hinausgeht. Der Fokus liegt auf \u003Cstrong>hochkomplexen parenteralen Peptid-Produkten\u003C\u002Fstrong>, bei denen tiefgehendes regulatorisches Know-how sowie eigenständige Dossier-Erstellung erforderlich sind.\u003C\u002Fp> \u003Chr> \u003Ch3>\u003Cstrong>Rahmendaten\u003C\u002Fstrong>\u003C\u002Fh3> \u003Cul> \u003Cli> \u003Cp>\u003Cstrong>Start:\u003C\u002Fstrong> kurzfristig \u002F nach Absprache\u003C\u002Fp> \u003Cli> \u003Cp>\u003Cstrong>Laufzeit:\u003C\u002Fstrong> bis mindestens 31.12.2026 (Option auf Verlängerung)\u003C\u002Fp> \u003Cli> \u003Cp>\u003Cstrong>Auslastung:\u003C\u002Fstrong> ca. 1–2 FTE (flexibel aufteilbar)\u003C\u002Fp> \u003Cli> \u003Cp>\u003Cstrong>Einsatzort:\u003C\u002Fstrong> Hybrid\u003C\u002Fp> \u003C\u002Ful> \u003Chr> \u003Ch3>\u003Cstrong>Aufgaben\u003C\u002Fstrong>\u003C\u002Fh3> \u003Cul> \u003Cli> \u003Cp>Eigenständige Erstellung und Überarbeitung von \u003Cstrong>CMC-Dokumentationen (Modul 3)\u003C\u002Fstrong> für \u003Cstrong>Originalpräparate (parenterale Peptide)\u003C\u002Fstrong>\u003C\u002Fp> \u003Cli> \u003Cp>Planung, Strukturierung und Umsetzung von \u003Cstrong>Dossier-Neuerstellungen und -Ergänzungen\u003C\u002Fstrong>\u003C\u002Fp> \u003Cli> \u003Cp>Bereitstellung und Aufbereitung regulatorisch relevanter Daten für Einreichungen\u003C\u002Fp> \u003Cli> \u003Cp>Enge Abstimmung mit internen \u003Cstrong>Regulatory Affairs Experten\u003C\u002Fstrong> sowie angrenzenden Funktionen\u003C\u002Fp> \u003Cli> \u003Cp>Sicherstellung der Einhaltung aktueller \u003Cstrong>regulatorischer Anforderungen (EMA, FDA etc.)\u003C\u002Fstrong>\u003C\u002Fp> \u003Cli> \u003Cp>Unterstützung bei \u003Cstrong>regulatory filings\u003C\u002Fstrong>, Klassifizierungen sowie \u003Cstrong>Manufacturing Change Control\u003C\u002Fstrong>\u003C\u002Fp> \u003Cli> \u003Cp>Erstellung und Review von \u003Cstrong>Registrierungsdokumenten (DE\u002FEN)\u003C\u002Fstrong>\u003C\u002Fp> \u003C\u002Ful> \u003Chr> \u003Ch3>\u003Cstrong>Anforderungen (Must-have)\u003C\u002Fstrong>\u003C\u002Fh3> \u003Cul> \u003Cli> \u003Cp>Nachgewiesene Erfahrung in der \u003Cstrong>CMC-Dokumentation für Originalpräparate\u003C\u002Fstrong>\u003C\u002Fp> \u003Cli> \u003Cp>\u003Cstrong>Spezifische Expertise in parenteralen Peptid-Produkten\u003C\u002Fstrong> (zwingend erforderlich)\u003C\u002Fp> \u003Cli> \u003Cp>Fundiertes Know-how in \u003Cstrong>Modul 3 (Quality)\u003C\u002Fstrong> inkl. Struktur, Inhalte und Anforderungen\u003C\u002Fp> \u003Cli> \u003Cp>Tiefgehendes Verständnis regulatorischer Anforderungen (EMA\u002FFDA) für komplexe Produkte\u003C\u002Fp> \u003Cli> \u003Cp>Fähigkeit zur \u003Cstrong>eigenständigen Erstellung von Dossiers\u003C\u002Fstrong> (kein reines Zuarbeiten)\u003C\u002Fp> \u003Cli> \u003Cp>Mehrjährige Erfahrung im Bereich \u003Cstrong>Regulatory Affairs \u002F CMC Writing\u003C\u002Fstrong>\u003C\u002Fp> \u003Cli> \u003Cp>Sehr gute Deutsch- und Englischkenntnisse\u003C\u002Fp> \u003C\u002Ful>\n\nIhr persönlicher Ansprechpartner\n\nBei Fragen können Sie sich jederzeit melden!\n\nDavid Riepen\n\nConsultant Pharma\n\nMobil:\n\n+49 151 65743765\nE-Mail:\n\nE-Mail: d.riepen@neo-experts.com d.riepen@neo-experts.com\nGemeinsam zum perfekten Match.\n\nJetzt bewerben","de","3087","https:\u002F\u002Fwww.neo-experts.com\u002Fstellen-suche\u002Fcmc-regulatory-expert-m-w-d---fokus-peptid-parenterale-originalpraparate-4a4b0-c03d8",{"items":31},[32,55,74,94,109,128,151,165,183,197,215,230,245,256,274],{"id":33,"slug":34,"title":35,"skills":36,"budget":16,"duration":49,"location":50,"onsitePercent":51,"contractType":52,"foundAt":53,"category":54},5099,"ivd-product-lead-external-manufacturing","IVD Product Lead External Manufacturing",[37,38,39,40,41,42,43,44,45,46,47,48],"IVD product management","ISO 13485","IVDR","FDA 21 CFR","Product specification","Production process specification","Leadership","German","English","Engineering","Natural Science","OPEX\u002FCAPEX","12++ months","Rotkreuz",90,"temp_work","2026-05-21T12:06:25+00:00",{"id":22,"slug":23,"label":24},{"id":56,"slug":57,"title":58,"skills":59,"budget":16,"duration":70,"location":71,"onsitePercent":18,"contractType":19,"foundAt":72,"category":73},5004,"senior-analytical-scientist-hplcuhplc-biologics-2","Senior Analytical Scientist (HPLC\u002FUHPLC, Biologics)",[60,61,62,63,64,65,66,67,68,69],"HPLC","UHPLC","Chromatographie","Biologics","Proteinbiochemie","Methodenentwicklung","Thermo Fisher UHPLC-Systeme","Chromeleon Software","SEC","RP","ca. 9 Monate","Österreich","2026-05-21T08:16:11+00:00",{"id":22,"slug":23,"label":24},{"id":75,"slug":76,"title":77,"skills":78,"budget":16,"duration":16,"location":90,"onsitePercent":91,"contractType":19,"foundAt":92,"category":93},4585,"laborant-zellkultur-mwd","Laborant Zellkultur (m\u002Fw\u002Fd)",[79,80,81,82,83,84,85,86,87,88,89],"Anlagen","Auswertung","Entwicklung","Fermentation","GMP","Herstellung","Optimierung","Planung","Teamfähigkeit","Zellkultur","Zelllinien","Biberach an der Riß",100,"2026-05-20T02:26:18+00:00",{"id":22,"slug":23,"label":24},{"id":95,"slug":96,"title":97,"skills":98,"budget":16,"duration":16,"location":90,"onsitePercent":91,"contractType":19,"foundAt":107,"category":108},4550,"technischer-assistent-hplc-analytik-mwd","Technischer Assistent HPLC-Analytik (m\u002Fw\u002Fd)",[60,83,99,100,101,102,103,104,105,106],"Analytik","Methodenvalidierung","Dokumentation","Empower","LabWare-LIMS","MS-Office","Chemielaborant","Biologielaborant","2026-05-19T16:25:57+00:00",{"id":22,"slug":23,"label":24},{"id":110,"slug":111,"title":112,"skills":113,"budget":16,"duration":124,"location":125,"onsitePercent":51,"contractType":19,"foundAt":126,"category":127},4527,"project-engineer-mwd-pharma","Project Engineer (m\u002Fw\u002Fd) Pharma",[114,115,116,117,118,119,120,121,122,123],"Projektmanagement","GMP-Kenntnisse","Pharmazeutische Industrie","Verfahrenstechnik","Biotechnologie","Pharmatechnik","Chemieingenieurwesen","Maschinenbau","Englischkenntnisse","Kommunikationsfähigkeit","6 Monate","Ludwigshafen am Rhein","2026-05-19T14:35:32+00:00",{"id":22,"slug":23,"label":24},{"id":129,"slug":130,"title":131,"skills":132,"budget":16,"duration":147,"location":148,"onsitePercent":91,"contractType":19,"foundAt":149,"category":150},4515,"testing-von-medizingeraeten","Testing von Medizingeräten",[133,134,135,136,137,138,139,140,141,142,143,144,145,146],"Testing","Testspezifikation","Jira","Python","C","C#","SQL","ISTQB","Elektronik","Informatik","Requirements Management","Polarion","Netzwerk","Datenbanken","13 Monate","Bensheim","2026-05-19T14:26:47+00:00",{"id":22,"slug":23,"label":24},{"id":152,"slug":153,"title":154,"skills":155,"budget":159,"duration":160,"location":161,"onsitePercent":162,"contractType":19,"foundAt":163,"category":164},4422,"mfc-und-c-entwickler-fuer-medizinischen-bereich","MFC und C++ Entwickler für medizinischen Bereich",[156,157,158],"C++","MFC","Reportstellung","auf Anfrage","3 Monate +","Ingolstadt",10,"2026-05-19T09:30:24+00:00",{"id":22,"slug":23,"label":24},{"id":166,"slug":167,"title":168,"skills":169,"budget":16,"duration":179,"location":180,"onsitePercent":16,"contractType":52,"foundAt":181,"category":182},3781,"validation-manager-ingenieur-reinigungs","Validation Manager \u002F Ingenieur Reinigungs",[170,171,172,173,174,83,118,175,176,177,178],"Validierung","Qualifizierung","Sterilisationsvalidierung","Reinigungsvalidierung","Anlagenqualifizierung","Pharma","Veeva","eVAL","Autoklaven","9+ Monate","Basel","2026-05-19T08:46:18+00:00",{"id":22,"slug":23,"label":24},{"id":184,"slug":185,"title":186,"skills":187,"budget":16,"duration":147,"location":194,"onsitePercent":18,"contractType":19,"foundAt":195,"category":196},3733,"entwicklung-sensorsysteme","Entwicklung Sensorsysteme",[101,141,81,188,123,189,190,24,191,171,192,193,170],"Forschung und Entwicklung","Koordination","Medizinprodukte","Messtechnik","Software","Umsetzung","Mannheim","2026-05-19T08:26:47+00:00",{"id":22,"slug":23,"label":24},{"id":198,"slug":199,"title":200,"skills":201,"budget":16,"duration":212,"location":180,"onsitePercent":16,"contractType":52,"foundAt":213,"category":214},3684,"analytical-project-leader","Analytical Project Leader",[60,202,203,204,205,206,207,208,209,210,211],"UPLC","ICH-compliant method validation","cGMP","Small molecule drug development","Stability studies","Impurity profiling","Regulatory documentation","IND\u002FNDA","Analytical chemistry","Ph.D. or Master's degree","12+ months","2026-05-19T04:49:29+00:00",{"id":22,"slug":23,"label":24},{"id":216,"slug":217,"title":218,"skills":219,"budget":16,"duration":226,"location":180,"onsitePercent":91,"contractType":227,"foundAt":228,"category":229},3682,"verfahrensingenieur-fuer-biotechnologische-produktionsanlagen","Verfahrensingenieur für biotechnologische Produktionsanlagen",[117,118,83,220,221,175,222,223,114,224,225],"Upstream","Downstream","Process Engineering","Betriebsengineering","Deutsch","Englisch","12++ Monate","permanent","2026-05-19T04:49:18+00:00",{"id":22,"slug":23,"label":24},{"id":231,"slug":232,"title":233,"skills":234,"budget":16,"duration":212,"location":180,"onsitePercent":16,"contractType":52,"foundAt":243,"category":244},3679,"analytical-compliance-record-specialist","Analytical Compliance Record Specialist",[235,236,83,237,238,239,240,241,60,242],"Organic Chemistry","Analytical Chemistry","Quality Control","CAPA","Deviations","Change Control","Veeva Vault","Mass Spectrometry","2026-05-19T04:48:59+00:00",{"id":22,"slug":23,"label":24},{"id":246,"slug":247,"title":248,"skills":249,"budget":16,"duration":253,"location":180,"onsitePercent":16,"contractType":52,"foundAt":254,"category":255},3678,"quality-control-project-lead","Quality Control Project Lead",[237,83,204,236,250,60,251,242,252,45],"LIMS","Gas Chromatography","Waters Empower","12 months","2026-05-19T04:48:54+00:00",{"id":22,"slug":23,"label":24},{"id":257,"slug":258,"title":259,"skills":260,"budget":16,"duration":212,"location":50,"onsitePercent":16,"contractType":52,"foundAt":272,"category":273},3673,"validation-engineer","Validation Engineer",[261,262,263,264,265,38,266,267,268,269,270,271,44,45],"Validation","Qualification","Auditing","Quality functions","MDR","21 CFR 820","External Manufacturing","Blow Molding","Injection Molding","Process Risk Analysis","Statistical Data Analysis","2026-05-19T04:48:20+00:00",{"id":22,"slug":23,"label":24},{"id":275,"slug":276,"title":277,"skills":278,"budget":16,"duration":226,"location":50,"onsitePercent":91,"contractType":227,"foundAt":286,"category":287},3664,"maschinenfuehrer-anlagenfuehrer-mwd","Maschinenführer \u002F Anlagenführer (m\u002Fw\u002Fd)",[279,115,280,281,282,283,284,285],"Anlagenbedienung","SAP","Siebdruck","Dispensierung","Produktionserfahrung","3-Schicht-Bereitschaft","Deutschkenntnisse C1","2026-05-19T04:46:51+00:00",{"id":22,"slug":23,"label":24}]