Associate Director Regulatory Affairs

vor 4 Wochen


Munich, Deutschland qinX GmbH Vollzeit

Unser Kunde ist ein etabliertes, international tätiges Pharmaunternehmen mit Fokus in den Bereichen Gynäkologie, Neurologie und Rare Diseases.


Das Büro liegt im Herzen Münchens mit guter Anbindung.


Ihre Aufgaben:


  • Koordination und Verwaltung von Zulassungsanträgen für nationale Behörden
  • Überwachung der Einhaltung pharmazeutischer Vorschriften und behördlicher Genehmigungen
  • Sicherstellung der Pharmakovigilanz und Meldung von Sicherheitsproblemen
  • Leitung von Audits und Inspektionen, sowie Bearbeitung von Feststellungen
  • Beratung der Unternehmensleitung und Teamführung für regulatorische Angelegenheiten
  • Leitung und Entwicklung eines Teams für regulatorische Angelegenheiten


Stellenanforderungen:


  • Abschluss an einer Hochschule in Pharmazie, Pharmakologie oder einem verwandten Bereich
  • Breite Erfahrung in regulatorischen Angelegenheiten und Einhaltungsvorgängen in der Pharmaindustrie
  • Erfahrung mit der Verwaltung von Arzneimittelsicherheitssystemen und Pharmakovigilanz
  • Fundiertes Verständnis globaler regulatorischer Anforderungen und Standards zur Qualitätssicherung
  • Verhandlungssichere Deutschkenntnisse sowie fließende Englischkenntnisse


Benefits:


  • Unbefristeter Arbeitsvertrag mit ansprechendem Leistungspaket
  • Betriebliche Altersvorsorge
  • 30 Tage Urlaub im Jahr
  • Erstattung des MVG-Tickets


Sie haben Interesse an unserer offenen Vakanz? Dann bewerben Sie sich ganz einfach direkt hier und wir kommen zeitnah auf Sie zu


Wir freuen uns, Sie kennenzulernen



  • Munich, Deutschland Alexion Pharmaceuticals,Inc. Vollzeit

    Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and...

  • Associate Director Cmc

    vor 24 Stunden


    Munich, Deutschland Meet Recruitment Vollzeit

    85000 EUR - 85000 EUR - Munich, Germany - Permanent - Meet partner today with a mid-size and growing biotech who are dedicated to the development of novel therapeutics against acute and chronic diseases. They are stepping now from drug development into a commercial stage and are to build up a CMC department internally for the exciting upcoming times. Right...


  • Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: ***Associate Regulatory Affairs - EU Regulatory Procedural Management (M/F/x)***: - limited until 31.10.2024 -**: **The position**: Provide support for EU Regulatory Procedural Management for assigned projects including all pre - and post-authorisation activities ensuring a smooth run of regulatory...


  • Munich, Deutschland Cpl Life Sciences Vollzeit

    **Reference Number**: JO-2304-514347 Director of Regulatory Affairs - (EU Relocation) **Rate**: Negotiable **Job Type**: Permanent **Location**: Munich Director, Regulatory Affairs - Infectious Diseases Munich, Germany /Europe - Relocation Package Provided. **Salary**: Attractive salary plus benefits package (stock options, car allowance, bonus...


  • Munich, Deutschland Cpl Life Sciences Vollzeit

    **Reference Number**: JO-2304-514343 Director of Regulatory Affairs -Infectious Disease **Rate**: Negotiable **Job Type**: Permanent **Location**: Munich **Job Title**: Director, Regulatory Affairs - Infectious Diseases **Location**: Munich, Germany - Hybrid working **Salary**: Attractive salary plus benefits package (stock options, car allowance,...


  • Munich, Deutschland Progressive Recruitment NL Vollzeit

    Für ein biopharmazeutisches Unternehmen in München suchen wir zum nächstmöglichen Zeitpunkt eine/n **Regulatory Affairs Associate (m/w/d)** Supports the activities of the affiliate's Regulatory Affairs team to ensure that the company complies with country's applicable legislations and regulations pertaining to the portfolio (at all stages of the...


  • Munich, Deutschland Weleda Vollzeit

    Weleda ist die weltweit führende Herstellerin von zertifizierter Naturkosmetik und anthroposophischen Arzneimitteln. Für deren Entwicklung, Produktion und Vermarktung engagieren sich international rund 2500 Mitarbeitende. Unsere Produkte tragen ganzheitlich zu Gesundheit und Wohlbefinden des Menschen bei. Zukunftsorientierung, gesellschaftliches Engagement...


  • Munich, Deutschland OPTARES Gmbh & Co. KG Vollzeit

    [5840] Our client is a NASDAQ listed biotechnology company with the global Headquarter in Germany. The companies focus is the research and development of new medicines for the treatment of inflammatory diseases within a global development approach. Our client stands out for an excellent team of highly motivated and skilled individuals who put strong...


  • Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    Passion for Innovation. Compassion for Patients. With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business...


  • Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    Passion for Innovation. Compassion for Patients. With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world. In Europe, we focus on two areas: The goal of our Specialty Business...


  • Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    To provide European regulatory strategy support for assigned projects, products and non-project work. Act as a specialist in the area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a multi-disciplinary global product team, providing expertise on regulatory matters....


  • Munich, Deutschland Servier Vollzeit

    **Datum der Veröffentlichung**:31.07.2023**Stadt**:München**Land/Region**:DE**Vertragstyp**:unbefristet**Stellenanforderungs-ID**:3796Regulatory Affairs Officer - Wir suchen zum nächstmöglichen Termin einen Regulatory Affairs Officer (m/w/d).**Das erwartet Sie**: - Bearbeitung von Zulassungsunterlagen im Rahmen der Arzneimittelentwicklung nach...

  • Regulatory Affairs Cmc

    vor 2 Monaten


    Munich, Deutschland Stirling Q&R Ltd Vollzeit

    **Position: Regulatory Affairs CMC** **About the Company**: A renowned pharmaceutical consulting firm is currently seeking a Regulatory Affairs CMC expert with a strong background in **small molecules** and pharmaceuticals. This role offers the opportunity to provide expert guidance on regulatory strategies for drug development projects, ensuring adherence...


  • Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

    **Passion for Innovation. Compassion for Patients.**: ***Director/Sr. Director Regulatory Affairs** **Companion Diagnostics (M/F/x)**: ***Purpose of the function**: To provide Leadership for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products....

  • Associate Director

    Vor 4 Tagen


    Munich, Deutschland Gilead Sciences Vollzeit

    For Current Gilead Employees and Contractors: Please log onto your Internal Career Site At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies...


  • Munich, Deutschland Kaia Health Software GmbH Vollzeit

    at Kaia Health Software GmbHMünchen, Bavaria, Germany **Kaia is a mission-focused health technology company.** Our story began in 2016, when our founders Konstantin Mehl and Manuel Thurner, set out on a mission to bring affordable and accessible relief to millions of people with chronic conditions. No strangers to chronic pain themselves, they decided to...


  • Munich, Deutschland Daiichi Sankyo Europe Vollzeit

    Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products. The job holder provides innovative approaches to resolve complex regulatory issues and increase speed to patients. **Roles & Responsibilities**: - CDx development:...


  • Munich, Deutschland AstraZeneca Vollzeit

    **This is what you will do**: The Medical Advisor Metabolics is a member of the Medical Affairs Team and will provide scientific and medical leadership especially for metabolic indications in establishing an in depth understanding of the relevant medical landscape in relation to relevant disease states and Alexion products. The Medical Advisor Metabolics is...


  • Munich, Bayern, Deutschland Nonstop Consulting Vollzeit

    Our client, a highly respected regulatory consulting and services firm based in Munich, Germany, is offering a compelling opportunity for an experienced Regulatory Affairs Project Manager. Currently employing over 50 people and planning to expand to 80 within the next two years, our client provides a vibrant and ambitious work environment that nurtures both...


  • Munich, Bayern, Deutschland Nonstop Consulting Vollzeit

    Our client, a highly respected regulatory consulting and services firm based in Munich, Germany, is offering a compelling opportunity for an experienced Regulatory Affairs Project Manager. Currently employing over 50 people and planning to expand to 80 within the next two years, our client provides a vibrant and ambitious work environment that nurtures both...