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Kaufmännische Tätigkeiten » Regulatory Affairs & Management

Drug Regulatory Affairs Stellenangebote

Ihre Jobsuche nach Drug Regulatory Affairs Jobs ergab 100 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 Stellenanzeigen.de

Job vor 7 Tagen 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 Jobleads

Neu Job vor 9 Std. gefunden

Global Program Clinical Head- Dermatology

[...] (s) to support decision milestones, regulatory requirements, market access, and owns the risk benefit- assessment for the program (s) . The GCPH contributes to the disease [...] ensuring continuous evaluation of the drug safety profile, including safety monitoring of clinical studies and signal detection from post- marketing surveillance; serving as a core member [...] NIBR Research, Translational Medicine, Medical Affairs, Commercial, Portfolio Strategy, Health Economics Outcomes Research) , and internal decision boards To be successful in this role, you should [...]

Job vor 2 Tagen gefunden Director Health Economics Outcomes Research Real World Evidence Oncology- Europe Canada • München, Bayern [...] as Global/ International/ Country Medical Affairs, Market Access, Pricing, Commercial, Regulatory, and other stakeholders. Moreover, you will work with external stakeholders to support reimbursement submissions, collaborative research, and the identification of [...] impact HEOR has in the drug development process. Are at ease with an abundance of detail and complexity, yet mindful of the big picture. Ability to [...]

Job vor 2 Tagen 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 vor 8 Tagen 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 [...]

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 30.03.2024 Regulatory Affairs Associate Director • 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 Title:- Regulatory Affairs Associate Director Location:- Hampton, NJ Job Description: Travel: Home based location. Frequent on- site work at facilities in Buffalo, New [...]

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 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 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 vor 8 Tagen 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 13 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

Stellenangebot Drug Regulatory Affairs Job bei DENK PHARMA GmbH Co. KG

Job vom 04.05.2024 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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Stellenangebote Drug Regulatory Affairs Jobs bei Mindmatch.ai

Job vor 2 Tagen gefunden

Marketing Associate Director, Haematology, Germany (Remote)

• München Jazz Pharmaceuticals [...] functional team consisting of medical affairs, marketing, sales, network management, and market access in the brand planning. AMD will provide project management leadership to ensure brand [...] external business challenges and/ or regulatory issues. The AMD will own and lead focus growth for main brand. AMD will support the brand plans of 2 [...] Oncology and/ or haematology/ Orphan Drug experience PhD or equivalent Excellent IT skills- familiar with MS Word, Excel and Power Point Highly motivated, enthusiastic and inspirational [...]

Stellenangebot Drug Regulatory Affairs Job bei ARTO

Job vor 9 Tagen gefunden Medical Affairs Advisor (CRP) • bad homburg ARTO [...] pivotal role within the medical affairs, clinical development, and business unit brand teams, employing scientific and medical expertise alongside relevant clinical experience. Their primary objective is [...] Medicine teams throughout the entire drug development and clinical trial continuum. Specific duties include: Contributing to global and/ or regional clinical/ medical plans in their respective [...] and access initiatives. Engaging with regulatory bodies and government agencies. Conducting outreach medical activities targeted at the external clinical community, including thought leaders. Performing various medical [...]

Job vom 12.04.2024

Senior Manager Regulatory Affairs- Medical Writing

• freiburg im breisgau, BW Sci Pro Senior Manager Regulatory Affairs Medical Writing (m/f/x) Freiburg/ hybrid Unser Kunde ist ein familiengeführtes Pharmaunternehmen, das sich auf innovative Arzneimittel im Feld der Gastroenterologie [...] präklinischer und klinischer Module, Orphan Drug Designations, PIPs und Briefing- Dokumente. Regulatorische Betreuung von Entwicklungsprojekten, Fokus auf präklinische und klinische Fragestellungen, PIPs, Orphan Designation und Scientific [...]

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