Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Specialist - Berlin - Worldwide Clinical Trials
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Regulatory Affairs Specialist
vor 4 Wochen
Berlin, Berlin, Deutschland GULP – experts united VollzeitAre you a detail-oriented and organized professional with a passion for regulatory affairs in the pharmaceutical industry? Do you have a strong understanding of relevant legislation and experience with electronic submissions and internet-based systems?We are seeking a highly skilled Regulatory Affairs Specialist to join our team at GULP – experts united....
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Regulatory Affairs Specialist
vor 4 Wochen
Berlin, Berlin, Deutschland GULP – experts united VollzeitAre you a detail-oriented and organized professional with a passion for regulatory affairs in the pharmaceutical industry? Do you have a strong understanding of relevant legislation and experience with electronic submissions and internet-based systems?We are seeking a highly skilled Regulatory Affairs Specialist to join our team at GULP – experts united....
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Regulatory Affairs Specialist
vor 2 Wochen
Berlin, Berlin, Deutschland GULP – experts united VollzeitJobbeschreibungWir suchen einen Regulatory Affairs Specialist für unseren Standort in Berlin.Ihre AufgabenPlanung, Organisation und Durchführung von nationalen Verfahren zur Neuzulassung, Zulassungsverlängerung sowie zur Zulassungsänderung von ArzneimittelnMitarbeit an entsprechenden europäischen Verfahren (MRP, DCP, CP) für Arzneimittel in enger...
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Regulatory Affairs Specialist
vor 2 Wochen
Berlin, Berlin, Deutschland GULP – experts united VollzeitJobbeschreibungWir suchen einen Regulatory Affairs Specialist für unseren Standort in Berlin.Ihre AufgabenPlanung, Organisation und Durchführung von nationalen Verfahren zur Neuzulassung, Zulassungsverlängerung sowie zur Zulassungsänderung von ArzneimittelnMitarbeit an entsprechenden europäischen Verfahren (MRP, DCP, CP) für Arzneimittel in enger...
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Regulatory Affairs Specialist
vor 2 Wochen
Berlin, Berlin, Deutschland Parexel VollzeitParexel is seeking a highly skilled Regulatory Affairs Consultant to join our team.The ideal candidate will have expertise in regulatory affairs, specifically in German and Swiss markets, and experience working with Swissmedic and BfArM.Key responsibilities include providing strategic guidance on regulatory requirements and submissions, supporting national...
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International Regulatory Affairs Specialist
vor 2 Wochen
Berlin, Berlin, Deutschland Berlin-Chemie AG VollzeitJoin Our Team as a Regulatory Affairs ExpertBerlin-Chemie AG, a leading pharmaceutical company, is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our International Regulatory Affairs & Drug Safety Department, you will be responsible for the acquisition and regulatory management of international marketing...
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Regulatory Affairs Specialist
vor 2 Wochen
Berlin, Berlin, Deutschland GULP – experts united VollzeitRegulatory Affairs ManagerGULP – experts united is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements for our medical technology products.Key Responsibilities:Develop and maintain documentation for regulatory approvals in...
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Regulatory Affairs Specialist
vor 2 Wochen
Berlin, Berlin, Deutschland GULP – experts united VollzeitRegulatory Affairs ManagerGULP – experts united is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements for our medical technology products.Key Responsibilities:Develop and maintain documentation for regulatory approvals in...
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Regulatory Affairs Specialist
Vor 7 Tagen
Berlin, Berlin, Deutschland S-Communication Services GmbH VollzeitJobbeschreibungWir suchen einen erfahrenen Regulatory Affairs Specialist, der unsere Unternehmen bei der Koordination und Organisation von Projekten im regulatorischen Umfeld unterstützt.VerantwortlichkeitenKoordination und Organisation von Projekten im regulatorischen UmfeldUnterstützung bei der Durchführung von ProjektenÜberwachung der Umsetzung von...
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Regulatory Affairs Specialist
vor 1 Monat
Berlin, Berlin, Deutschland Parexel VollzeitAbout the Role:We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Parexel. As a key member of our regulatory team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Provide expert advice on new product applications and lifecycle maintenanceSupport...
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Regulatory Affairs Specialist
vor 3 Wochen
Berlin, Berlin, Deutschland GULP – experts united VollzeitRegulatory Affairs ManagerGULP – experts united is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements for our medical technology products.Key Responsibilities:Develop and maintain documentation for regulatory approvals in...
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Regulatory Affairs Specialist
vor 3 Wochen
Berlin, Berlin, Deutschland GULP – experts united VollzeitRegulatory Affairs ManagerGULP – experts united is seeking a highly skilled Regulatory Affairs Manager to join our team in Berlin. As a key member of our team, you will be responsible for ensuring compliance with regulatory requirements for our medical technology products.Key Responsibilities:Develop and maintain documentation for regulatory approvals in...
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Regulatory Affairs Specialist
vor 2 Wochen
Berlin, Berlin, Deutschland Parexel VollzeitAbout the Role:We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Parexel. As a key member of our regulatory team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Provide expert advice on new product applications and lifecycle maintenanceSupport...
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Regulatory Affairs Specialist
vor 3 Wochen
Berlin, Berlin, Deutschland Parexel VollzeitUnlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Consultant to join our dynamic team at Parexel. As a key member of our team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Develop and implement regulatory strategies to ensure...
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Regulatory Affairs Specialist
vor 3 Wochen
Berlin, Berlin, Deutschland Parexel VollzeitUnlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Consultant to join our dynamic team at Parexel. As a key member of our team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Develop and implement regulatory strategies to ensure...
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Regulatory Affairs Specialist
vor 1 Monat
Berlin, Berlin, Deutschland Parexel VollzeitAbout the Role:We are seeking a highly skilled Regulatory Affairs Consultant to join our team at Parexel. As a key member of our regulatory team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Provide expert advice on new product applications and lifecycle maintenanceSupport...
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Regulatory Affairs Specialist
vor 4 Wochen
Berlin, Berlin, Deutschland Parexel VollzeitUnlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Consultant to join our dynamic team at Parexel. As a key member of our team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Develop and implement regulatory strategies to ensure...
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Regulatory Affairs Specialist
vor 4 Wochen
Berlin, Berlin, Deutschland Parexel VollzeitUnlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Consultant to join our dynamic team at Parexel. As a key member of our team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Develop and implement regulatory strategies to ensure...
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Regulatory Affairs Specialist
vor 3 Wochen
Berlin, Berlin, Deutschland Parexel VollzeitUnlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Consultant to join our dynamic team at Parexel. As a key member of our team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Develop and implement regulatory strategies to ensure...
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Regulatory Affairs Specialist
vor 3 Wochen
Berlin, Berlin, Deutschland Parexel VollzeitUnlock Your Potential in Regulatory AffairsWe are seeking a highly skilled Regulatory Affairs Consultant to join our dynamic team at Parexel. As a key member of our team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Develop and implement regulatory strategies to ensure...
Regulatory Affairs Specialist
vor 5 Monaten
**Requisition Number**
**6512**
**Employment Type***:
**Regular**
**Who we are**
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
We are Worldwide Clinical Trials, and we are a global team of almost 3000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
**What you will do**
- Liaise with colleagues to plan, organize, compile, progress, track and submit regulatory submissions on a timely basis. Where required provide local QC of submission dossiers prior to dispatch
- Effectively communicate to the Lead and relevant project team members the status and action plans concerning submissions and advise the project team about appropriate regulatory strategies
- Review and make recommendations on all relevant documentation e.g. labels, patient information sheets, diary cards etc. to comply with ICH GCP & country specific requirements
**What you will bring to the role**
***
- Strong organizational and management skills
- Self-motivated learning about current regulatory processes and intelligence
- Excellent written and verbal communication skills to clearly and concisely present information
- Team-oriented work style; seeks and gives guidance to others
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Excellent ability to handle multiple tasks in a fast-paced and changing environment
**Your background**
***
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science
- Minimum one year of experience in clinical research, in regulatory-related function
- Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidance
- Multilingualism preferred; fluent in local language; working knowledge of English
**Why Worldwide**
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
LI-MZ1
