Regulatory Affairs Manager
vor 4 Wochen
Company Overview
Miltenyi Biomedicine is a biopharmaceutical company dedicated to developing personalized chimeric antigen receptor (CAR) T-cell therapies. Our mission is to improve and prolong patients' lives by creating innovative treatments for serious life-threatening diseases.
Job Summary
- Manage and lead regional teams of regulatory affairs professionals in the EU and EMEA for new and approved products on a national or international basis.
- Coordinate strategic regulatory activities with full staff and product management authority, as well as regional regulatory strategy and planning in line with the global regulatory strategy.
- Work closely with health authorities to coordinate, communicate, and manage all regulatory interactions.
- Oversee relevant aspects of product safety and quality regarding pharmacovigilance and regulatory requirements.
- Lead the development and maintenance of prescribing information and risk management plans.
Requirements
- M.D., Ph.D., or Master's degree in pharmacy, biology, chemistry, or a related field. An advanced degree or certificate in regulatory science is preferred, but not required.
- Several years of relevant experience in EU regulatory affairs, drug development, and/or submission management with a focus on ATMPs and biologics.
- Sound business judgment and collaborative skills, as well as proven ability to interact and influence at all levels of a dynamic organization.
- Ability to build and maintain strong cross-functional relationships, to challenge traditional views while respecting best practices, and to present and argue cases in a professional and respectful manner.
- Proven track record of successfully leading and developing a team.
- Self-starter with excellent organizational and communication skills in English, basic skills in German are preferred, but not required. Willingness to travel internationally.
What We Offer
- A modern workplace in Bergisch Gladbach with opportunity for some mobile work.
- Exciting opportunities in the development of technologies with a secure future.
- Cross-border intercultural cooperation and short communication channels.
- A collegial corporate culture and flexible working hours enable time management on your own terms.
- Personalized employee development program: specialist and personal training courses provided by our own Miltenyi University.
- Diverse corporate benefits with regard to employee health, sport, and staff events.
-
Regulatory Affairs Manager
vor 4 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec VollzeitIhre AufgabenWir suchen einen motivierten und engagierten Regulatory Affairs Manager, der sich in unserer dynamischen und innovativen Umgebung einbringen möchte.Sie verfügen über fließende Deutsch- und Englischkenntnisse in Wort und Schrift und sind sicher im Umgang mit MS Office, Outlook und Windows-Betriebssystemen.Arbeiten mit freier und...
-
Regulatory Affairs Leader
vor 4 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitCompany OverviewMiltenyi Biomedicine is a leading biopharmaceutical company focused on developing innovative treatments for serious life-threatening diseases. Our mission is to improve and prolong patients' lives through the development of personalized chimeric antigen receptor (CAR) T-cell therapies.Job SummaryWe are seeking a highly experienced Regulatory...
-
Regulatory Affairs Specialist
vor 4 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitCompany OverviewMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. We are pioneering groundbreaking treatments for serious life-threatening diseases, aiming to improve and extend patients' lives.Job ResponsibilitiesManage investigational and approved advanced medicinal therapy products on a...
-
Global Regulatory Affairs Professional
vor 3 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitCompany OverviewMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to develop groundbreaking treatments for serious life-threatening diseases, making them accessible globally for clinical professionals and patients.Key ResponsibilitiesManage investigational and approved advanced...
-
Global Regulatory Affairs Specialist
vor 2 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitCompany OverviewMiltenyi Biomedicine is a biopharmaceutical company pioneering groundbreaking therapies for serious life-threatening diseases. Our mission is to advance personalized cell and gene therapies, improving and extending patients' lives worldwide.SalaryThe estimated annual salary for this position ranges from $120,000 to $180,000, depending on...
-
Scientific Program Manager
vor 4 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec VollzeitScientific Leadership Opportunity at Miltenyi BiotecAs a highly skilled Scientist, you will lead a team focused on the research and development of novel reagents, assays, and workflow solutions for analytics in NK, NK-CAR, GD-T cell, and GD-CAR T cell therapies. Your expertise in immunology and disease biology will drive the strategic planning,...
-
Post-Market Surveillance Specialist
vor 4 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec VollzeitJob Title: Post-Market Surveillance ManagerJob Summary:We are seeking a highly skilled Post-Market Surveillance Manager to join our team at Miltenyi Biotec. As a key member of our organization, you will be responsible for the post-market surveillance of our clinical products, including medical devices, in vitro diagnostics, and GMP products.Key...
-
Scientific Program Manager
vor 4 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec VollzeitJob Title: Scientific Program ManagerJob Summary:We are seeking a highly skilled Scientific Program Manager to lead our research and development efforts in the field of immunotherapy. The successful candidate will have a strong background in immunology and disease biology, with experience in managing scientific programs and leading teams to success.Key...
-
Master Data Spezialist
vor 4 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec VollzeitStellenbeschreibungSie werden Teil unserer agilen Produktorganisation und arbeiten an unserem unternehmensweiten Serialisierungsprojekt mit, in dessen Rahmen jedes unserer Produkte per Label rückverfolgbar ist.Sie sind verantwortlich für die Optimierung des Label Management Systems und wichtige Schnittstelle zu Key Playern.Perspektivisch begleiten Sie das...
-
Datenexperte für Label Management
vor 4 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec VollzeitStellenbeschreibungSie werden Teil unserer agilen Produktorganisation und arbeiten an unserem unternehmensweiten Serialisierungsprojekt mit, in dessen Rahmen jedes unserer Produkte per Label rückverfolgbar ist.Sie sind verantwortlich für die Optimierung des Label Management Systems und wichtige Schnittstelle zu Key Playern.Perspektivisch begleiten Sie das...
-
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec VollzeitJob OverviewAs a key member of Miltenyi Biotec's R&D department, this role is responsible for leading a team focused on the research and development of advanced immunotherapy solutions. The successful candidate will play a critical role in driving the company's immunotherapy pipeline from early development through to commercialization.Key...
-
Senior Immunology Process Coordinator
vor 4 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec VollzeitOverviewThe ideal candidate for this role will have a strong background in immunological techniques and clinically relevant process development. This position involves coordinating the development and market release of the CliniMACS Prodigy system, which includes novel solutions for the automated and completely closed production of genetically modified T...
-
Senior Immunotherapy Coordinator
vor 4 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec VollzeitImmunotherapy Team Coordinator RoleAt Miltenyi Biotec, we are seeking a highly skilled Immunotherapy Team Coordinator to join our team. This exciting role involves coordinating the development and market release of the CliniMACS Prodigy system, which includes novel solutions for the automated and completely closed production of genetically modified T cells...
-
Clinical Trial IMP Manager
vor 4 Wochen
Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine VollzeitClinical Trial IMP Manager Job DescriptionIn the Clinical Trial Execution Service department, you will support our study processes and activities in line with our go-to-market strategy for investigational medicinal products (IMPs), particularly in haematological and oncological indications. You will be the expert and first point of contact for IMP-related...
-
Manager - Global Regulatory Affairs - ATMP (m|f|d)
vor 6 Monaten
Bergisch Gladbach, Deutschland Miltenyi Biomedicine VollzeitCompany Description Miltenyi Biomedicine is a biopharmaceutical company developing personalized chimeric antigen receptor (CAR) T-cell therapies. We are developing innovative treatments for serious life-threatening diseases and are reshaping their accessibility to patients worldwide with the goal of improving and prolonging patients' lives. We are...
-
Global Regulatory Affairs Manager
vor 5 Monaten
Bergisch Gladbach, Deutschland Miltenyi Biomedicine VollzeitCompany Description Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We...
-
Product Manager
vor 1 Woche
Bergisch Gladbach, Deutschland Miltenyi Biotec VollzeitJob DescriptionWe are seeking a highly motivated and results-oriented Product Manager (m|f|d) to join our team and manage the assigned portfolio of CliniMACS Disposables / Bags. In this role, you will play a pivotal role in driving product development, market positioning, and customer satisfaction within the exciting field of cell and gene therapy. You...
-
Regulatory Affairs Manager
vor 6 Monaten
Bergisch Gladbach, Deutschland Miltenyi Biotec VollzeitIhre Aufgaben mit Voraussicht und motiviert an. Sie verfügen über fließende Deutsch- und Englischkenntnisse in Wort und Schrift und sind sicher im Umgang mit MS Office, Outlook und Windows-Betriebssystemen. Zusätzliche Informationen Was wir bieten Arbeiten mit freier und selbstbestimmter Zeiteinteilung Ein interkulturelles Umfeld, geprägt...
-
Manager - Translational Research (m|f|d)
vor 1 Monat
Bergisch Gladbach, Deutschland Miltenyi Biotec VollzeitJob DescriptionAs a Manager in Miltenyi Biotec's R&D department, you lead a group focused on the research in basic mechanisms and development of analytical methods and reagents to support Miltenyi's immunotherapy pipeline from early clinical development through to commercialization.The focus is on native and gene-modified NK cells and Gamma-Delta T cells....
-
(Junior) Post-Market Surveillance Manager
vor 4 Monaten
Bergisch Gladbach, Deutschland Miltenyi Biotec VollzeitJob DescriptionYou will join our team responsible for the post-market surveillance (PMS) of our clinical products (medical devices, in vitro diagnostics and GMP products) and perform organizational and administrative tasks to manage PMS data. You will be responsible for the management of PMS data collected from various sources (e.g. feedback,...
-
Master Data
vor 6 Monaten
Bergisch Gladbach, Deutschland Miltenyi Biotec VollzeitMaster Data & LMS Expert – Biotech & Biomedicine (m|w|d) IT and Software Engineering - Bergisch Gladbach Unternehmensbeschreibung Seit mehr als Jahren entwickeln wir einzigartige Lösungen für die biomedizinische Spitzenforschung sowie neuartige Zell- und Gentherapien. Wir tragen dazu bei, Methoden der Medizin zu revolutionieren, um Krebs...
-
Technical Writer
vor 4 Wochen
Bergisch Gladbach, Deutschland Miltenyi Biotec VollzeitJob DescriptionYou will be responsible for creating and maintaining user manuals in English for our innovative medical devices, always ensuring compliance with current standards and regulatory requirements. You will organize the translation of user manuals into the languages relevant to the target market with our translation team. Additionally, you will...
-
Visionary Leader
Vor 2 Tagen
Bergisch Gladbach, Deutschland Miltenyi Biotec VollzeitJob DescriptionYou will be responsible for developing and enhancing our software for our cutting-edge analysis devices. This enables researchers to visualize and analyze biological structures and interactions in unprecedented detail, particularly in neurology, immunology and cancer research. In addition, you will lead a cross-functional department and act as...
-
Team Coordinator
vor 1 Monat
Bergisch Gladbach, Deutschland Miltenyi Biotec VollzeitJob DescriptionIn this exciting role you join a motivated team focused on developing the next generation CliniMACS Prodigy® T cell application for clinical use. You will coordinate the development and market release of the CliniMACS Prodigy® system which includes novel solutions for the automated and completely closed production of genetically modified T...
-
TMF Specialist
Vor 6 Tagen
Bergisch Gladbach, Deutschland Miltenyi Biomedicine VollzeitJob DescriptionIn this role, you will be responsible for collecting, reviewing, maintaining, and archiving essential regulatory documents for the Trial Master File (TMF) in accordance with Good Clinical Practice (GCP), E6 ICH Guidelines and other regulatory guidance documents, and Clinical Trials Regulation, and our Standard Operating Procedures (SOPs).You...
-
Clinical Trial Manager
vor 3 Monaten
Bergisch Gladbach, Deutschland Miltenyi Biomedicine VollzeitJob DescriptionIn the Clinical Trial Execution Service department you will support our study processes and activities in line with our go-to-market strategy for investigational medicinal products (IMPs), particularly in haematological and oncological indications. You will be the expert and first point of contact for IMP-related questions of the study team...
