Drug Regulatory Manager Stellenangebote

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Stellenangebote Drug Regulatory Manager Jobs bei Neuvoo.com

Job vom 28.10.2024 Takeda GmbH

Manager MS T Lab DS (f/m/d)

• Singen

MEHR

[...] true to the best of my knowledge. Job Description Are you looking for a patient- oriented, innovation- driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a Manager MS T Lab DS (f/m/d) Lead a dynamic team at the forefront of vaccine development, driving innovation and efficiency in biopharmaceutical manufacturing processes, while shaping the future of Takeda s global dengue vaccine operations. Responsibilities: Establish, lead and manage the MS T Drug Substance Lab Team, overseeing USP and DSP activities while optimizing resource utilization for ad- hoc support and long- term improvements. Collaborate with MS T, CMC, QA, QC, regulatory, and manufacturing teams to enhance processes and support technology transfers in global vaccine manufacturing. Establish and maintain the Drug Substance [...]

Job vom 24.10.2024 Takeda GmbH Process Engineer Drug Product (f/m/d) • Singen

MEHR

[...] the best of my knowledge. Job Description Are you looking for a patient- oriented, innovation- driven company that inspires you and promotes your career? Then take your future in your hands and become part of Takeda as a Process Engineer Drug Product (f/m/d) In this role, you will work in an international team on exciting technical topics related to the global [...] advanced technologies and process harmonization, while providing technical leadership for resolving product line issues and major projects. Serve as the primary technical interface between Technical Operations and drug product manufacturing sites, ensuring support for troubleshooting, Change Controls, investigations, CAPAs, and regulatory inspections. Collaborate with Development and Site Operations teams for technology transfers, risk assessments, and innovative solutions. Support the engineering, qualification, and validation of new and existing vaccine manufacturing processes, including fill finish and visual inspection, in line with global regulations. In this position you will report to the Manager Vaccines MS T Drug Products. Your profile: Bachelor s or Master s in Chemical, Biochemical, Biotechnology, Biopharmaceutical Engineering, or related [...]

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Neu Job vor 7 Std. gefunden Gerresheimer AG

Manager Regulatory Affairs Validierung Pharmaindustrie (m/w/d)

• Bünde Flexible Arbeitszeiten Tarifvertrag

MEHR

Über Gerresheimer Gerresheimer ist der globale Partner für Pharmazie, Biotech, Gesundheit und Kosmetik mit einem sehr breiten Produktspektrum für Arzneimittel- und Kosmetikverpackungen sowie Drug Delivery Devices. Das Unternehmen ist ein innovativer Lösungsanbieter vom Konzept bis zur Lieferung des Endprodukts. Gerresheimer erreicht seine ehrgeizigen Ziele [...] erwirtschaftet im Geschäftsjahr 2023 einen Jahresumsatz von rund 2 Mrd. Euro. Gerresheimer spielt mit seinen Produkten und Lösungen eine wesentliche Rolle für die Gesundheit und das Wohlbefinden von Menschen. Stellenbeschreibung Für unseren Produktionsstandort in Bünde suchen wir einen Leiter Validierung Regulatory Affairs (m/w/d) . In dieser Funktion sind Sie für die Leitung und Weiterentwicklung des globalen Regulatory Affairs- und Validierungsteams im [...]

Neu Job vor 7 Std. gefunden Gerresheimer AG Senior Regulatory Affairs Manager (m/w/d) • Bünde Flexible Arbeitszeiten Tarifvertrag

MEHR

Über Gerresheimer Gerresheimer ist der globale Partner für Pharmazie, Biotech, Gesundheit und Kosmetik mit einem sehr breiten Produktspektrum für Arzneimittel- und Kosmetikverpackungen sowie Drug Delivery Devices. Das Unternehmen ist ein innovativer Lösungsanbieter vom Konzept bis zur Lieferung des Endprodukts. Gerresheimer erreicht seine ehrgeizigen Ziele [...] Geschäftsjahr 2023 einen Jahresumsatz von rund 2 Mrd. Euro. Gerresheimer spielt mit seinen Produkten und Lösungen eine wesentliche Rolle für die Gesundheit und das Wohlbefinden von Menschen. Stellenbeschreibung Für unseren Produktionsstandort in Bünde suchen wir einen Global Head of Validation Regulatory Affairs (m/w/d) . In dieser Funktion sind Sie für die Leitung und Weiterentwicklung des globalen Regulatory Affairs- und Validierungsteams im [...]

Stellenangebote Drug Regulatory Manager Jobs bei Jobleads

Job vom 13.10.2024

Drug Product Manager (Reporting to the Vice President CMC IP)

• Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen

MEHR

Drug Product Manager (Reporting to the Vice President CMC IP) As a Drug Product Manager, you will be part of our CMC management drug product team supporting all clinical projects with respect to product quality, CMO management, and CMC documentation for regulatory dossiers. Your mission As a Drug Product Manager, you will be part of our CMC management drug product team supporting [...]
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Job vom 01.09.2024 General Manager, Germany

MEHR

About Prilenia Prilenia Therapeutics, a clinical- stage biotechnology company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is seeking a General Manager, Germany, to join our European Leadership Team. We are a flexible, fast- moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington s disease (HD) and amyotrophic lateral sclerosis (ALS) in the U. S. and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is anticipating a regulatory filing in HD in mid- 2024 in the EU and preparing for a global Phase 3 clinical trial in ALS. [...]
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Job vom 19.06.2024

Neurology Medical Director (Associate/ Senior)

Führungs-/ Leitungspositionen

MEHR

[...] research through our PPD clinical research portfolio. People and communities that rely on improved health outcomes today and in the future will benefit from your commitment to providing quality and accuracy. Discover impactful work: Throughout all stages of the clinical drug development process, this role offers tactical oversight and strategic leadership for the clinical and medical components. In compliance with relevant [...] out clinical development plans (CDPs) , clinical trials, and procedures. This individual oversees and participates in the documenting of study outcomes, the analysis of study results, and the evaluation of how well the study or studies have met clinical or regulatory goals. In meetings with partners (such as vendors, consultants, etc. ) , external audiences, and external stakeholders (such as collaborators, [...] such as not being able to access the career website, getting in touch with someone about an application, or other technical problems unrelated to a disability, wont be answered. Job Title: Stem Cell Laboratory Technologist Job Title: Assistant Digital Marketing Manager Job Title: Outlet Manager- Mekong Restaurant Job Title: Medical translator/ proof reader Job Title: Post doctor in Medical Radiation Sciences [...]
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Stellenangebote Drug Regulatory Manager Jobs bei StepStone

Job gestern gefunden Heidelberg Pharma AG (Senior) Manager Clinical Quality Assurance (m/f/d) • Ladenburg bei Mannheim Homeoffice möglich

MEHR

Heidelberg Pharma AG sucht in Ladenburg bei Mannheim eine/n (Senior) Manager Clinical Quality Assurance (m/f/d) (ID- Nummer: 11735056) . As a medium- sized company based in Ladenburg near Heidelberg, we attach [...] and take responsibility for our work area. Together we are working on a new treatment approach in oncology. Based on our ADC technologies, we are developing novel drugs for the targeted and highly effective treatment of cancer. ADCs are antibody drug conjugates that combine the specificity of antibodies with the efficacy of toxins to fight cancer. We use several compounds and [...] risk- based approach to quality Support Head of QA in implementing a risk- based GxP Quality Management, risk management and audit planning Support the implementation and the maintenance of inspection readiness concepts and the preparation, hosting, and follow up of regulatory inspections Be an integral part of interdisciplinary project teams as quality advisor Organise and conduct quality related trainings to colleagues [...]

Job vor 4 Tagen gefunden EXTEDO GmbH

Marketing Specialist/ Marketing Manager (m/f/d) B2B

• Ottobrunn bei München Homeoffice möglich

MEHR

EXTEDO GmbH sucht in Ottobrunn bei München eine/n Marketing Specialist/ Marketing Manager (m/f/d) B2B (ID- Nummer: 11707119) . EXTEDO helps health authorities and pharmaceutical companies around the world develop and bring new drugs and vaccines to market faster and more safely. As an internationally leading provider of software and services in regulatory information management (RIM) , we support life sciences organizations in implementing the requirements of the regulatory authorities for their products. [...] that medicines and vaccinations reach where they are needed faster and, at the same time, more safely: with the patients. Regulatory authorities around the world also rely on us to review submissions and ensure they meet the highest standards of drug safety. For our location in Ottobrunn near Munich we are actively seeking a Marketing Specialist/ Marketing Manager (m/f/d) B2B Support [...]
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Job vom 30.10.2024 SCHOTT Pharma AG Co. KGaA Manager Regulatory Affairs (m/f/d) • Mainz Beratungs-/ Consultingtätigkeiten Homeoffice möglich

MEHR

SCHOTT Pharma AG Co. KGaA sucht in Mainz eine/n Manager Regulatory Affairs (m/f/d) (ID- Nummer: 11660499) . SCHOTT is a leading international technology group in the areas of specialty glass and [...] regulatory issues with agents and consultants Lead interdisciplinary teams to establish new processes, enhancing regulatory contributions to the business Serve as the go- to advisor and trainer for internal SCHOTT- Pharma- specific regulatory topics, such as National Product Registrations and Drug Master Files (DMFs) Roll out and oversee standards and central specifications for Dossier- structures across global markets for our customers [...]

Stellenangebote Drug Regulatory Manager Jobs bei Freelance.de

Job vor 2 Tagen gefunden

Für Freelancer- Medical Manager/ Medical Scientific Liaison Manager ? Rare Disease (m/f/d)

• Zug Freiberuflich

MEHR

[...] actively ? Medical expertise in the x- functional collaboration (local brand team) ? Advising internal stakeholders on product- specific and other medical requests/ Ensure proper documentation of relevant medical insights into designated internal documentation tools and prepare medical statements and drug information ? Close support of the specialist departments (Regulatory, Market Access, PV) and of the release promotional and medical information material ? Plan, design and execute medical education events [...]

Job vom 08.10.2024 Für Freelancer- Medical Alliance Operations Leader (m/f/d) • Basel Führungs-/ Leitungspositionen Freiberuflich

MEHR

[...] Management: Monitor and manage clinical research processes to ensure quality and compliance with applicable regulations and standards ? Study Team Coaching and Training: Provide guidance, training, and support to study teams to enhance their understanding of clinical research processes and regulatory requirements ? Support Inspection and Audit Preparation and Follow- up: Prepare for and support inspections and audits by regulatory authorities [...] Life Sciences ? Relevant experience in pharmaceutical or medical device area ? Proven experience with ISO 14155, ISO 20916, and ISO 13485 and awareness of applicable global regulations (21 CFR 812, EU IVDR, EU MDR) ? In- depth knowledge of drug, IVD, device combination, multi- standard studies, and combined studies ? Strong skills in process development, implementation, and infrastructure development ? [...]

Job vom 02.10.2024

Für Freelancer- Regional Regulatory Lead (m/f/d)

• Bern Führungs-/ Leitungspositionen Freiberuflich

MEHR

Freelancer Projekt- Ihre Aufgaben: ? Serve as a Regional Regulatory Lead for the assigned product portfolio (Therapeutic area Immunology, Respiratory, Transplant) and countries ? Align all regulatory activities with regional [...] connectivity ? Stay informed about international legislation and guidelines for biological products and related initiatives e. g. , rare diseases, orphan drugs Ihre Qualifikationen: ? A degree in Life Sciences, preferably with a post- graduate qualification. Degree e. g. in Drug Regulatory Affairs advantageous ? Regulatory experience within the international region, supported by additional pharmaceutical or industry experience ? Understanding of [...]

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