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Kaufmännische Tätigkeiten » Regulatory Affairs & Management

Drug Regulatory Affairs Stellenangebote

Ihre Jobsuche nach Drug Regulatory Affairs Jobs ergab 136 Stellenangebote

Stellenangebote Drug Regulatory Affairs Jobs bei StepStone

Job vom 24.04.2024

Principal Biostatistics (m/f/x)

• München, Europa Daiichi Sankyo Europe GmbH Feste Anstellung, Homeoffice möglich, Vollzeit [...] reporting (CSR) . Support Medical Affairs and HEOR/ HTA strategies: Set- up additional statistical analyses required, including analyses of patient- reported outcomes (PROs) and health economic [...] Contribute to documents submitted to regulatory or pricing authorities. May participate as subject matter expert in meeting or teleconferences with health authorities. Responsible for providing direction [...] of experience as statistician supporting drug development and/ or post marketing in Clinical research, Pharmaceutical company, CRO or Medical Device setting Experience in oncology Therapeutic Area [...]

Stellenangebote Drug Regulatory Affairs Jobs bei Jobvector

Job gestern gefunden Biotechnologist- Process Engineering (m/f/d) • Frankfurt am Main BioNTech SE Vollzeit [...] team of process owners for Drug Substances, all modalities. In this function the position holder takes ownership for commercial or late clinical stage manufacturing process (es) [...] AS T, tech Dev. , Regulatory Affairs, QA) and external partners Drive continuous improvement to enhance process robustness; monitoring of KPIs in collaboration with internal stakeholders (e. [...]

Job gestern gefunden

Biologist (f/m/x)

• Frankfurt am Main BioNTech SE Vollzeit [...] team of process owners for Drug Substances, all modalities. In this function the position holder takes ownership for commercial or late clinical stage manufacturing process (es) [...] AS T, tech Dev. , Regulatory Affairs, QA) and external partners Drive continuous improvement to enhance process robustness; monitoring of KPIs in collaboration with internal stakeholders (e. [...]
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Job gestern gefunden Biotechnologist- Process Engineering (m/f/d) • Mainz BioNTech SE Vollzeit [...] team of process owners for Drug Substances, all modalities. In this function the position holder takes ownership for commercial or late clinical stage manufacturing process (es) [...] AS T, tech Dev. , Regulatory Affairs, QA) and external partners Drive continuous improvement to enhance process robustness; monitoring of KPIs in collaboration with internal stakeholders (e. [...]

Job gestern gefunden

Biotechnologist- Process Engineering (m/f/d)

• Mannheim BioNTech SE Vollzeit [...] team of process owners for Drug Substances, all modalities. In this function the position holder takes ownership for commercial or late clinical stage manufacturing process (es) [...] AS T, tech Dev. , Regulatory Affairs, QA) and external partners Drive continuous improvement to enhance process robustness; monitoring of KPIs in collaboration with internal stakeholders (e. [...]

Job gestern gefunden Biologe (f/m/x) • Mannheim BioNTech SE Vollzeit [...] team of process owners for Drug Substances, all modalities. In this function the position holder takes ownership for commercial or late clinical stage manufacturing process (es) [...] AS T, tech Dev. , Regulatory Affairs, QA) and external partners Drive continuous improvement to enhance process robustness; monitoring of KPIs in collaboration with internal stakeholders (e. [...]
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Stellenangebote Drug Regulatory Affairs Jobs bei Jooble

Job vor 2 Tagen gefunden

Clinical Drug Safety Manager (m/w/d)

CO. DON GmbH [...] (PVA, SDEA) Enge Zusammenarbeit mit Regulatory Affairs, Produktion, Qualitätssicherung und externen Servicedienstleistern Perspektivisch Übernahme der Funktion des Stufenplanbeauftragten (m/w/d) und QPPV (m/w/d) Was Sie mitbringen Erfolgreich abgeschlossenes [...]

Stellenangebote Drug Regulatory Affairs Jobs bei Stellenanzeigen.de

Neu Job vor 11 Std. gefunden Labormitarbeiter (all genders) Biologics Drug Product Development • 67061, Ludwigshafen am Rhein, Deutschland Abb Vie Deutschland GmbH Co. KG Labormitarbeiter (all genders) Biologics Drug Product Development Abb Vies Mission ist es, innovative Medikamente zu entdecken, die im Heute schwerwiegende Gesundheitsprobleme lösen und die medizinischen [...] Forschungsassistent, Qualitätskontrolleur, Bioprozessingenieur, Biomedizinischer, Ingenieur, Regulatory, Affairs, Specialist, Projektmanager, Naturwissenschaftler, Chemikant, Laborant DUBLETTEOVERRIDE 82100176 [...]
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Stellenangebote Drug Regulatory Affairs Jobs bei Neuvoo.com

Job vom 28.04.2024

QA/ RA Manager (API)

• Munich Flavine [...] world of GMP and GDP regulatory requirements, crafting, reviewing, and maintaining SOPs that are fully compliant. Take charge of organizing and supervising the execution of our [...] quality- related matters. API Regulatory Affairs aspects: Preparation, review and submission of high- quality DMF and cCEP applications for Active Pharmaceutical Ingredients for submission to European [...] post approval changes to respective Drug Master Files Effective communication with customers to ensure successful product registration by providing open part DMF, technical package and other [...]
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Stellenangebote Drug Regulatory Affairs Jobs bei Jobleads

Job gestern gefunden Medical Director, Medical Affairs- GSA • München, Bayern [...] team consisting of 6 Scientific Affairs Managers (SAMs) in Germany and with a dotted line 2 Country Operations Leads (COLs) in their medical function in Austria [...] Demonstrated in- depth understanding of drug development and local regulations relating to promotional activities. Ability to travel as necessary (up to 50 ) . More about [...] researchers, a track record of regulatory successes and global commercial infrastructure to develop a full portfolio of treatment options to patients struggling with hyperphagia and severe [...]
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Job vom 30.03.2024

Medical Director Medical Affairs Oncology/ Hematology

• München, Bayern Medical Director Medical Affairs Oncology/ Hematology Full- time Transition from medical practice to Bio Pharma Industry Clinical Physician Real work/ life balance. 40 hour [...] scientific methodology, protocol design, and regulatory requirements designated for review by regulatory authorities. Proven successful management of teams either directly, or in a matrix environment, with [...] partnership specializes in placing clinical drug development professionals and represents clients ranging from small research labs to major biotech and pharma companies. Collectively we have orchestrated [...]
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Job vom 29.03.2024 Sr. Principal Scientist Toxicologist • München, Bayern [...] provide scientific expertise across the drug discovery and development value chain on biotherapeutics and small molecules. Activities include, but are not limited to: Serve as Preclinical [...] small molecule drug candidates for regulatory submissions. These activities include designing and coordinating a multi- disciplinary effort to support such projects through the development of the [...] with multiple functions (Pharmacology, Regulatory Affairs, Clinical, Project Leaders Managers, etc. ) on a daily basis Involved with the multiple Community of Practice groups in preclinical [...]

Job vom 29.03.2024

Senior Regulatory Publisher

• München, Bayern [...] immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners. Job Description Job Description The Contract Regulatory Publisher s primary role is to provide document and sequence level publishing and compilation for US, EMA and RoW regulatory [...] and external resources on Regulatory Affairs related issues. The Contract Regulatory Publisher supports adherence to relevant regulatory requirements and company SOPs as appropriate. This is a [...]

Job vom 29.03.2024 Senior Medical Director Medical Safety Evaluation • München, Bayern [...] product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC) . Implements relevant policies to ensure the safety of the product in global development and [...] drug and appropriate and timely regulatory reporting of safety issues. KEY RESPONSIBILITIES As designated Global Safety Team Chair (GST Chair) for assigned products, is responsible for [...] and operational) , MTDA regulatory affairs, and global quality/ manufacturing Oversees data collection, processing, assessment, and preparation ofannual reports, and periodic reports to ensure the timely [...]

Job vom 29.03.2024

Regulatory Affairs Leader (Associate Director)

• München, Bayern Regulatory Affairs Leader (Associate Director) Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is [...] agencies, including knowledge experience applying drug or device laws regulations for product registration, adverse event reporting, recalls. Ability to prioritize, plan evaluate deliverables to established strategic [...]
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Weitere Stellenangebote Drug Regulatory Affairs bei StepStone

Job gestern gefunden Drug Regulatory Affairs Manager (m/w/d) 80- 100 • Schwäbisch Gmünd WELEDA AG Feste Anstellung, Homeoffice möglich, Teilzeit, Vollzeit [...] sucht in Schwäbisch Gmünd eine/n Drug Regulatory Affairs Manager (m/w/d) 80- 100 (ID- Nummer: 11077233) . Weleda ist die weltweit führende Herstellerin von zertifizierter Naturkosmetik und anthroposophischen Arzneimitteln. [...]

Job vor 6 Tagen gefunden

Specialist or Manager Regulatory Affairs CMC (m/w/d)

• Berlin Aurora Europe GmbH Feste Anstellung, Homeoffice möglich, Vollzeit [...] CMC (m/f/d) zur Verstärkung unseres Drug Regulatory Affairs Teams. Eigenverantwortliche Bewertung, Erstellung, Optimierung und Aktualisierung von regulatorischen Dokumenten bzgl. chemisch- pharmazeutischer Qualität (Modul 2. 3 und 3) für [...]

Job vom 24.04.2024 Pharmazeut im Praktikum (m/w/d) • Berlin Pfizer Pharma GmbH Befristeter Vertrag, Vollzeit [...] und nachhaltig zu verbessern - Regulatory Affairs/ Arzneimittelzulassung (Intensivprakt. ) : Wird ein neuer Wirkstoff entdeckt, beginnt die Entwicklung des Medikaments und die Arbeit in der Arzneimittelzulassung. [...] Zulassung erfüllt sein müssen - Drug Safety/ Arzneimittelsicherheit (Kombipraktikum mit I I oder Onkologie) : Der Bereich der Arzneimittelsicherheit prüft und bewertet Verdachtsfälle von unerwünschten Arzneimittelwirkungen, [...]
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Weitere Jobs Drug Regulatory Affairs bei StepStone

Job vor 11 Tagen gefunden

Manager (m/w/d) Regulatory Affairs für Deutschland die EU

• München DENK PHARMA GmbH Co. KG Feste Anstellung, Homeoffice möglich, Vollzeit [...] 2 Jahre Berufserfahrung im Bereich Drug Regulatory Affairs, idealerweise im Bereich CMC/ Modul 3 Kommunikationsstärke und hoher Teamspirit sowie Freude daran, mit unterschiedlichen Kulturen zusammenzuarbeiten Eine sehr exakte, [...]
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