Regulatory Affairs Specialist

vor 4 Wochen

Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

Company Overview

Miltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to improve and extend patients' lives by pioneering groundbreaking therapies for serious life-threatening diseases.

Job Summary

  • As a Regulatory Affairs representative, you will be responsible for managing investigational and approved advanced medicinal therapy products on a national or international basis.
  • You will provide regional regulatory strategy and planning in line with the global regulatory strategy, working closely with health authorities to coordinate, communicate, and manage all regulatory interactions.
  • Contribute to product safety and quality aspects regarding pharmacovigilance and regulatory requirements.
  • Manage the development and maintenance of prescribing information and risk management plans.

Requirements

  • M.D., Ph.D., or other degree in pharmacy, biology, chemistry, or a related field. An advanced degree or certificate in regulatory science is preferred.
  • 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.
  • 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.

  • Global Regulatory Affairs Specialist

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi Biomedicine is a biopharmaceutical company dedicated to advancing personalized cell and gene therapies. Our mission is to improve and extend patients' lives by developing groundbreaking treatments for serious life-threatening diseases.Job SummaryAs a Regulatory Affairs representative, you will be responsible for managing...

  • Regulatory Affairs Leader

    vor 3 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company 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 Vollzeit

    Company 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 Specialist

    Vor 7 Tagen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company 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...

  • Regulatory Affairs Manager

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Job Title: Regulatory Affairs Manager - ATMPCompany 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...

  • Regulatory Affairs Manager

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company OverviewMiltenyi 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 SummaryManage and lead regional teams of regulatory affairs professionals...

  • Global Regulatory Affairs Professional

    vor 3 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biomedicine Vollzeit

    Company 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...

  • Regulatory Affairs Manager

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec Vollzeit

    Ihre 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...

  • Senior T Cell Development Specialist

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec Vollzeit

    Job Title: Senior T Cell Development SpecialistJob Summary:We are seeking a highly skilled Senior T Cell Development Specialist to join our team at Miltenyi Biotec. As a key member of our development team, you will be responsible for coordinating the development and market release of the CliniMACS Prodigy system, which includes novel solutions for the...

  • Regulatory Affairs Manager

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec Vollzeit

    Ihre AufgabenWir suchen eine motivierte und engagierte Person, die 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 selbstbestimmter ZeiteinteilungEin...

  • Senior T Cell Development Specialist

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec Vollzeit

    Job Title: Senior T Cell Development SpecialistJob Description:In this exciting role, you will be part of a motivated team focused on developing the next generation CliniMACS Prodigy T cell application for clinical use. Your primary responsibility will be to coordinate the development and market release of the CliniMACS Prodigy system, which includes novel...

  • Post-Market Surveillance Specialist

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec Vollzeit

    Job 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...

  • Content Creation Specialist for Medical Devices

    Vor 7 Tagen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec Vollzeit

    Job Description:As a Technical Writer, you will be responsible for creating and maintaining high-quality user manuals for our innovative medical devices. Your primary focus will be on ensuring compliance with current standards and regulatory requirements. You will work closely with our translation team to organize the translation of user manuals into...

  • Master Data Spezialist

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec Vollzeit

    StellenbeschreibungSie 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 Vollzeit

    StellenbeschreibungSie 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...

  • Medical Device Documentation Specialist

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec Vollzeit

    Job Title: Technical WriterJob Description:We are seeking a skilled Technical Writer to join our team at Miltenyi Biotec. As a Technical Writer, you will be responsible for creating and maintaining user manuals for our innovative medical devices. Your primary focus will be on ensuring compliance with current standards and regulatory...

  • Executive Director of Immunotherapy Research and Development

    vor 3 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec Vollzeit

    Job 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...

  • Scientific Program Manager

    vor 3 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec Vollzeit

    Scientific 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,...

  • Senior Immunology Process Coordinator

    vor 3 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec Vollzeit

    OverviewThe 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 Research Manager

    vor 4 Wochen

    Bergisch Gladbach, Nordrhein-Westfalen, Deutschland Miltenyi Biotec Vollzeit

    Job Title: Senior Research Manager - ImmunotherapyAbout the Role:We are seeking a highly skilled and experienced Senior Research Manager to lead our Immunotherapy research team at Miltenyi Biotec. As a key member of our R&D department, you will be responsible for the strategic planning, implementation, and management of our project portfolio focused on...