Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Specialist - Berlin, Berlin - Staphyt
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Regulatory Affairs Specialist
vor 3 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 3 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 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 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 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 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 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 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 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 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 2 Wochen
Berlin, Berlin, Deutschland Olympus VollzeitJob Title: Regulatory Affairs ManagerAs a key member of the Olympus team, the Regulatory Affairs Manager plays a vital role in ensuring the company's products comply with international regulations. This includes providing regulatory guidance, supporting product launch compliance, and maintaining expertise in evolving industry standards.Key...
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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...
Regulatory Affairs Specialist
vor 2 Monaten
We are seeking an experienced and motivated Ecotoxicology Specialist to join our multinational Environment Team in Europe. As a key member of our Regulatory Affairs Division, you will play a crucial role in supporting our clients in successfully bringing active substances and products to the market.
Key Responsibilities- Data Gap Analysis (DGA): Conduct thorough analysis of data gaps and develop early phase testing strategies to ensure compliance with regulatory requirements.
- Study Design and Monitoring: Design and monitor laboratory and field ecotoxicological studies, including management of studies delivered through Contract Research Organizations (CROs) and budget responsibilities.
- Registration Dossier Preparation: Draft relevant sections of registration dossiers, including IUCLID format, and undertake risk assessments, including higher-tier refinements.
- Client Support and Communication: Provide strategic advice to clients and represent them in communication with Regulatory Authorities.
- Team Collaboration: Work closely with our Regulatory Team and/or directly with client teams to ensure a joined-up and consistent approach across all areas of expertise.
- Relevant Scientific Degree: Hold a relevant scientific degree, such as a Bachelor's or Master's degree in a field related to ecotoxicology or a related field.
- Regulatory Experience: Possess at least 5 years of experience in one or several relevant EU/UK regulatory regimes, either gained as a consultant, evaluator, or within industry.
- Strong Analytical and Communication Skills: Demonstrate the ability to understand and accurately interpret data from studies and complex risk assessments, and to communicate effectively with clients and Regulatory Authorities.
- Team Player: Be a team player with strong decision-making skills and a keen ability to work in an international business environment.
- Knowledge of IUCLID: Possess knowledge of IUCLID, the International Uniform Chemical Information Database.
