Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Specialist - Berlin, Berlin - 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 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 1 Woche
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...
Regulatory Affairs Specialist
vor 2 Monaten
**About the Role**
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at GULP – experts united. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our pharmaceutical products with regional and global regulations.
**Key Responsibilities**
- Develop, align, and implement approval strategies to ensure earliest possible submissions and first-cycle approvals with target designations for assigned development projects on a global basis.
- Assess and align the likelihood of success for the assigned development projects.
- Interact with health authorities to present, validate, and negotiate development plans and product labeling.
- Develop regulatory strategy for assigned projects by designing and evaluating regulatory strategy options on a regional and global basis.
- Develop local and global regulatory project objectives from development to life cycle management.
- Lead a global regulatory team (GRT) and coordinate global regulatory input into the global development plan of assigned projects.
**Requirements**
- Advanced technical degree (Ph.D., DVM, or Pharm D.) in life sciences, preferably with several years of medical research experience, including local and global regulatory experience in a related TA field.
- Expert knowledge of regional HA regulations and advanced knowledge of global regulations and proven interaction with local health authorities.
- Proven leadership and project management skills, including cross-functional communication, interpersonal, and influencing skills.
- Ability to knowledgeably discuss and effectively deal with issues such as product safety and pharmaceutical regulatory compliance.
- Fluency in written and spoken German and English.
**What We Offer**
- Attractive remuneration (€75,000 gross per year).
- Vacation entitlement of up to 30 days per year.
- Competent contact persons on site at the branch office.
- Regular team events such as summer parties and Christmas parties.
- Discounted membership of around 2,900 sports, leisure, and wellness facilities with Gympass.
