Drug Regulatory Manager Stellenangebote

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Stellenangebote Drug Regulatory Manager Jobs bei Neuvoo.com

Neu Job vor 10 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 10 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 Stellen-Online

Job vor 14 Tagen gefunden Miltenyi Biomedicine GmbH

IMP Manager- Clinical Trials (m f d) - Homeoffice, Vollzeit

• 51429, Bergisch Gladbach, 51429 Homeoffice möglich

MEHR

[...] coordinate and execute IMP- related trial processes and activities such as Chain of Identity (CoI) and Chain of Custody (CoC) management and requirements planning to ensure efficient and compliant supply of fresh and frozen IMP, including documentation in accordance with regulatory requirements. This includes monitoring the lifecycle of IMP and comparator products from receipt to destruction, including labelling design, packaging, IWRS (Interactive Response Technology) set- up, distribution and drug accountability. As the orchestration of logistics processes is critical to the product flow of our CAR- T clinical trials, you [...]
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Stellenangebote Drug Regulatory Manager Jobs bei JobMESH

Stellenangebot Drug Regulatory Manager Job bei Gerresheimer AG

Job vom 22.10.2024 Gerresheimer AG Manager Regulatory Affairs Validierung Pharmaindustrie (m/w/d) • Nordrhein- Westfalen 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 [...]

Job vom 22.10.2024 Gerresheimer AG

Senior Regulatory Affairs Manager (m/w/d)

• Nordrhein- Westfalen 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 Stellenanzeigen.de

Job vor 4 Tagen gefunden Aptar Radolfzell GmbH Quality Services Project Manager CHC (m/f/d) • 78253, Eigeltingen, Deutschland

MEHR

QUALITY SERVICES PROJECT MANAGER CHC (m/f/d) Your new challenge at our site in Eigeltingen: Quality representative and active member in global operations/ manufacturing projects: [...] standards (ISO 13485 and 15378) : You will ensure the application of these standards in all projects and establish cooperation between the quality units of the sites. Partner with international customers in the pharma industry: You understand the quality and regulatory framework for our customers products and provide valuable quality support. Contributing to design control and control strategy of our products: [...] is key to our success. We welcome applications from all members of society irrespective of age, sex, disability, sexual orientation, race, religion or belief. Your new employer: Aptar Pharma is part of Aptar Group, Inc. , a global leader in drug and consumer product dosing, dispensing and protection technologies. Aptar serves a number of attractive end markets including pharmaceutical, beauty, food, [...]

Job vor 9 Tagen gefunden Storz Bickel GmbH

Leiter Qualitätsmanagement und Compliance (m/w/d)

• 78532, Tuttlingen, Deutschland Führungs-/ Leitungspositionen Abgeschlossenes Studium Betriebliche Altersvorsorge Weihnachtsgeld

MEHR

[...] gemacht: STORZ BICKEL ist der erste und einzige Hersteller von zertifizierten Medizinprodukten für die Inhalation von Cannabinoiden. Unser Unternehmen wächst stetig gerne mit Dir. Leiter Qualitätsmanagement und Compliance (m/w/d) Deine Aufgaben Führung Strategie Leitung der Abteilung Compliance mit Fokus auf Regulatory Affairs, Qualitäts- Management und Qualitätssicherung Festlegung der Zertifizierungsstrategie: Medizinprodukte/ UL 8139/ Drug- Device- Combination, etc. Produktkonformität Zulassungen Verantwortung für sämtliche Produktzulassungen und deren Aufrechterhaltung in Zusammenarbeit mit internen und externen Stellen Sicherstellung [...] gerne für dich da Ansprechpartner: +49 (7461) 969707- 0 jobs storz- bickel. com STORZ BICKEL GmbH In Grubenäcker 5 9, 78532 Tuttlingen jobs storz- bickel. com www. storz- bickel. com . Ingenieur, Maschinenbau, Maschinenbauingenieur, Elektrotechnik, Elektroingenieur, Projektleiter, Qualitätsmanagement, Qualitätsmanager, Compliance, Manager, Risikomanager, Risikoanalyse, Risikomanagement, Medizintechnik, Techniker, Medizintechniker, Elektrotechniker, Leiter, Qualitätssicherung, Zertifizierung, Prozessoptimierung 26042318 [...]
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Stellenangebote Drug Regulatory Manager Jobs bei Jobleads

Job vor 7 Tagen gefunden Medical Director Multiple Sclerosis • Basel, Basel- Stadt Führungs-/ Leitungspositionen

MEHR

[...] patients as soon as possible. Your main responsibilities are: Lead and/ or support cross- functional teams to design and execute clinical development plans from Phase 1 through Phase 2 (proof- of- concept) Coach Clinical Scientists in a line- or functional- manager status Closely interface with project team leaders as well as safety, clinical pharmacology, clinical operations, biostatistics, regulatory, research and biomarker groups and other members of project teams Lead and/ or support internal stakeholder management and governance interactions [...] MD/ PhD with a speciality in neuroimmunology, multiple sclerosis, or a similar field. Board certification and fellowship training or research experience in relevant areas is preferred. You bring at least 5 years of experience in longitudinal clinical research, preferably in drug development or clinical trials. You hold a strong track record of scientific excellence in the field, evidenced by substantial achievement [...]

Job vom 13.10.2024

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

• Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen

MEHR

Your mission 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. Responsibilities Coordination of pre- formulation and compatibility studies within the formulation development Project management of pharmaceutical development and manufacturing [...]
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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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Jobs aus StepStone

Stellenangebote Drug Regulatory Manager Jobs bei StepStone

Job vor 5 Tagen gefunden Formycon AG

Master Data Specialist (gn) Supply Chain Logistics

• Martinsried/ Planegg Homeoffice möglich

MEHR

Formycon is an international leading, independent developer of high- quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of around 240 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process. Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon [...] as possible with access to vital and affordable medicines. To support our team in Martinsried near Munich, we are looking for suitable candidates for this full- time and permanent position, to begin work as soon as possible. The Master Data Manager will be responsible for overseeing the creation, maintenance, and governance of master data within the organization. This role ensures the [...]
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Stellenangebot Drug Regulatory Manager Job bei Universitätsklinikum Heidelberg

Job vor 11 Tagen gefunden Universitätsklinikum Heidelberg Project Manager- Rare Disease Research Project (m/f/d) • Heidelberg Homeoffice möglich Jobticket

MEHR

[...] employees in more than 50 specialized clinical departments with almost 2, 500 beds, about 80, 000 patients in part- time and full- time inpatient treatment as well as 1, 000, 000 patients in ambulant treatment are medicated each year. Project Manager- Rare Disease Research Project (m/f/d) wanted for the next possible date at the Centre for Pediatrics and Adolescent Medicine for [...] 1. Facilitate the integration of existing rare disease registry data into well- structured cohorts suitable for clinical trials, ensuring transparency and accessibility. 2. Assist in coordinating the creation of robust natural history cohort data for specific diseases, adhering to high regulatory standards. 3. Collaborate on the creation of a model- based clinical trial simulation (CTS) platform for rare diseases, focusing on disease progression modeling and regulatory- grade drug development tools. 4. Facilitate the development of a platform for creating regulatory- grade patient- relevant Clinical Outcome Assessments (COAs) in [...]

Job vom 30.11.2024 EXTEDO GmbH

Senior IT Project Manager/ IT Consultant (m/f/d) Focus Health Agencies

• Ottobrunn bei München, Home- Office Beratungs-/ Consultingtätigkeiten Homeoffice möglich

MEHR

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 (or in remote within Germany) we are actively seeking a Senior Project Manager/ Consultant (m/f/d) Focus Health Agencies As a Senior Project Manager, you will be responsible for driving engagement deliveries to Health [...]
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Job vom 27.11.2024 Formycon AG Senior Clinical Trial Supply Manager (gn) • Planegg, Martinsried Teilzeit Homeoffice möglich

MEHR

Formycon is an international leading, independent developer of high- quality biopharmaceutical medicines, especially biosimilars. With an experienced team comprised of around 240 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process. Our focus is on treatments in ophthalmology and immunology as well as for other key chronic diseases. Formycon [...] in Martinsried near Munich, we are looking for suitable candidates for this full- or part- time (min. 32 hrs/ week) and permanent position, to begin work as soon as possible. As an experienced and highly skilled Senior Clinical Trial Supply Manager (gn) you will lead the planning, execution, and oversight of the supply chain for our clinical trials. In this critical [...]

Job vom 20.11.2024 Heidelberg Pharma AG

(Senior) Manager Clinical Quality Assurance (m/f/d)

• Ladenburg bei Mannheim Homeoffice möglich

MEHR

[...] 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 [...] great company events await you Would you like to work with us today on the medicine of tomorrow for the benefit of patients? Then become part of our team . Heidelberg Pharma AG sucht in Ladenburg bei Mannheim eine/n (Senior) Manager Clinical Quality Assurance (m/f/d) (ID- Nummer: 11735056) 21022457 [...]

Job vom 17.11.2024 EXTEDO GmbH Marketing Specialist/ Marketing Manager (m/f/d) B2B • Ottobrunn bei München Homeoffice möglich

MEHR

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 the team to draft a yearly marketing plan, including an estimated budget Plan and conduct multi- channel [...]
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Stellenangebote Drug Regulatory Manager Jobs bei Neuvoo

Stellenangebot Drug Regulatory Manager Job bei CK Group

Job vor 2 Tagen gefunden CK Group

QA Auditor Compliance Manager

• Switzerland, CH

MEHR

Overview: We are seeking a highly skilled and experienced QA Auditor Compliance Manager, to ensure GMP compliance at third party service providers and within internal facilities. The successful candidate will lead or assist [...] personnel and suppliers to schedule, execute and follow up with audit observations. Promptly report critical self- inspection findings to the Responsible Person and Management. Create, implement, maintain, and work with Vendors on establishing Quality Agreements where needed. Interface between quality/ regulatory/ compliance personnel and operations to identify applicable regulatory and compliance requirements. Manage, review and approve change controls, deviations and CAPAs [...] Traveling (20 - 30 ) may be required, including international travel. Qualifications: University degree in Pharmacy, Chemistry or alternative technical/ science university degree: master level minimum. Minimum 3 years experience in Auditing, 1 as Lead Auditor. Knowledge and understanding of drug product development, manufacturing processes, as well as quality control, packaging and distribution aspects. Excellent knowledge of relevant GMP/ GDP and [...]

Stellenangebot Drug Regulatory Manager Job bei Wu Xi App Tec

Job vor 11 Tagen gefunden Wu Xi App Tec Quality Control Senior Scientist • 2108 Couvet, NE, Switzerland

MEHR

The Senior Scientist is part of the the Quality Control (QC) department of STA Pharmaceuticals Switzerland. The Team is responsible for introducing new raw materials, drug substance (API) , and drug product (Bulk) as well as new technologies at the site. The Senior Scientist provides technical [...] qualification supplier Audit, participating to cleaning validation and validation processes, and leading QC risk assessments. The Senior Scientist assists other technical support team members with questions and technical issues and acts as a point of contact in absence of the Manager. He/ she plays an expert role and shares know- how with colleagues regarding methods, deviation, CAPA, Change control and QC [...] well as deviations and investigations handling. Takes a structured and analytical approach to problem solving. Is familiar with problem- solving and investigation tools and methodologies Able to present topics as Subject Matter Expert to internal audience, external audience and at regulatory inspections and audits. Excellent scientific knowledge and hands- on experience of chromatography techniques (HPLC, UPLC, GC) , dissolution, UVNIS and [...]

Stellenangebot Drug Regulatory Manager Job bei FLEXSIS

Job vom 03.12.2024 FLEXSIS

QA Manager Combination Product and Device (m/f/d)

• Basel, Basel, CH Homeoffice möglich

MEHR

EINFÜHRUNG: As a preferred supplier for F. Hoffmann- La Roche Ltd. in Basel, we are looking for a motivated QA Manager Combination Product and Device (m/f/d) This is a full/ part- time position (80- 100 ) with an unlimited duration. The [...] SPOC (single point of contact) for allocated Device Development project and ensure all projects follow the applicable design control and risk management procedures Collaborate with all QA representatives from other functions to ensure Quality Robustness of the interface between the Drug Product and the Device Component forming the Combination Product Create and deploy Risk Management Plan/ Report, actively participate up to [...] quality or device development Demonstrated capability of applying risk management concepts and tools, and deploying Design Control Understanding of the biotechnology industry and specifically combination products and working in a global environment preferred Sound knowledge of cGMPs and relevant international regulatory requirements (QSR; MDR; ISO13485, etc. ) Well developed teamwork and collaboration skills and ability to communicate clearly and professionally both [...]
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