Regulatory Affairs Leadership Expert

Vor 4 Tagen


Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit
Job Overview
Arevipharma GmbH seeks a seasoned Head of Regulatory Affairs to lead our Regulatory Affairs team. This key role oversees all regulatory processes, ensuring compliance with applicable standards and driving continuous improvement initiatives within the department.

About the Role
This is a leadership position that requires experience in team management, with a focus on leading regulatory projects, consolidating data from various departments to produce regulatory reports and dossier sections. The ideal candidate will have a deep understanding of drug regulatory affairs and be proficient in English and German (fluency required).

Salary
The estimated salary for this position is €80,000 - €110,000 per year, commensurate with experience. Benefits include various tax-advantaged offerings, such as contributions towards childcare costs, and free beverages.

Responsibilities
- Lead all regulatory processes and ensure compliance with applicable standards
- Drive continuous improvement, optimization, and digitalization initiatives within the Regulatory Affairs department
- Independently manage regulatory projects, consolidating data from various departments to produce regulatory reports and dossier sections
- Prepare and update active substance dossiers (including QOS)

Qualifications
- Completed university degree (preferably as a pharmacist or chemist), ideally with a Ph.D. and a Master's in Drug Regulatory Affairs
- Minimum of 5 years of experience in Drug Regulatory Affairs
- Demonstrated experience in team and personnel management
- Proficient in English and German (fluency required); additional languages such as French or Spanish are an advantage

Benefits
- Finanzielle Unterstützung: Various tax-advantaged offerings and contributions towards childcare costs
- Getränke: Free beverages

  • Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit

    About the RoleWe are seeking an experienced Head of Regulatory Affairs to join our team at Arevipharma GmbH. This is a strategic leadership opportunity where you will oversee and manage the Regulatory Affairs team, providing functional and disciplinary leadership for on-site and remote employees.Key ResponsibilitiesLead all regulatory processes and ensure...


  • Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit

    Job Description:Arevipharma GmbH is seeking a highly experienced Regulatory Affairs Director to lead our team in ensuring compliance with applicable standards. About the Role:This strategic leadership position involves overseeing and managing the Regulatory Affairs team, providing functional and disciplinary leadership for on-site and remote employees. The...


  • Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit

    About Arevipharma GmbHWe are a dynamic company looking for an experienced professional to join our Regulatory Affairs team as a Head of Compliance Management.Job DescriptionThe successful candidate will oversee and manage the Regulatory Affairs team, providing leadership and direction to on-site and remote employees across various locations. The role...


  • Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit

    Arevipharma GmbH, a leading manufacturer of pharmaceutical active substances and intermediates with over 150 years of history, is seeking an experienced professional to lead its Regulatory Affairs team. This role offers a unique opportunity for a seasoned regulatory expert to oversee the development and implementation of regulatory strategies that support...


  • Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit

    About Arevipharma GmbHA modern manufacturer of pharmaceutical active substances and intermediates with a nearly 150-year-old tradition, serving generic and research-based pharmaceutical companies on five continents.Job SummaryWe are seeking an experienced Head of Regulatory Affairs to lead our regulatory team and ensure compliance with applicable...


  • Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit

    Located in a thriving region, Arevipharma GmbH is a pioneering pharmaceutical company with a nearly 150-year-old legacy. Our diverse client base spans five continents, including generic and research-driven pharmaceutical companies.We are seeking an experienced Senior Regulatory Affairs Strategist to lead our Regulatory Affairs team.Key...


  • Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit

    Job DescriptionAs a leading manufacturer of pharmaceutical active ingredients and intermediates, Arevipharma GmbH is seeking an experienced Regulatory Affairs professional to join our team. We are looking for a highly skilled individual to oversee all regulatory processes, ensure compliance with applicable standards, and drive continuous improvement...


  • Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit

    About the RoleWe are seeking an experienced Senior Regulatory Affairs Director to lead our Compliance Management team at Arevipharma GmbH. As a key member of our Regulatory Affairs team, you will oversee and manage regulatory processes, ensuring compliance with applicable standards.Key Responsibilities:Lead all regulatory processes, guaranteeing adherence to...


  • Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit

    As a Regulated Affairs Director at Arevipharma GmbH, you will be responsible for overseeing the entire regulatory process and ensuring compliance with applicable standards. Our ideal candidate has a minimum of 5 years of experience in Drug Regulatory Affairs, preferably with a Ph.D. and a Master's in Drug Regulatory Affairs.Job ResponsibilitiesLead all...


  • Dresden, Sachsen, Deutschland Vality One Recruitment GmbH Vollzeit

    Deine AufgabenAls Regulatory Affairs Manager bist du für die Umsetzung von regulatorischen Anforderungen in der pharmazeutischen Entwicklung verantwortlich. Du sicherst, dass regulatorische Vorgaben in die Erstellung und Einreichung von Unterlagen einfließen.Deine QualifikationenAbgeschlossenes Studium im naturwissenschaftlichen BereichMin. 2 Jahre...


  • Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit

    ÜberblickDie Arevipharma GmbH ist ein etablierter Hersteller pharmazeutischer Wirkstoffe und Zwischenprodukte mit einer nahezu 150-jährigen Tradition. Wir zählen generische und forschende Pharmaunternehmen auf fünf Kontinenten als Kunden.GehaltWir bieten ein attraktives Gehalt von ca. €120.000 bis €180.000 pro Jahr, je nach Erfahrung und...


  • Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit

    Bei der Arevipharma GmbH erwarten Sie eine Herausforderung im Bereich Arzneimittelzulassung. Wir suchen einen erfahrenden Regulatory Affairs Leiter/in, um unser Team zu stärken.Wer sind wir?Als moderner Hersteller pharmazeutischer Wirkstoffe und Zwischenprodukte mit einer nahezu 150-jährigen Tradition zählen zu unseren Kunden generische und forschende...


  • Dresden, Sachsen, Deutschland Vality One Recruitment GmbH Vollzeit

    ÜberblickBei Vality One Recruitment GmbH suchen wir einen erfahrenden Regulatory Affairs Manager, der sich auf die strategische Planung von regulatorischen Anforderungen in der pharmazeutischen Entwicklung spezialisiert hat.LohnDer Bruttostundenlohn liegt bei etwa 45 bis 55 € pro Stunde. Insgesamt können wir eine monatliche Nettovergütung von 5500 bis...


  • Dresden, Sachsen, Deutschland Arevipharma GmbH Vollzeit

    At Arevipharma GmbH, we are seeking a seasoned Compliance Management Expert to lead our Regulatory Affairs team.About the RoleWe are looking for a highly experienced professional to oversee and manage the Regulatory Affairs team, providing functional and disciplinary leadership to on-site and remote employees across various locations and affiliates.Main...


  • Dresden, Sachsen, Deutschland Vality One Recruitment GmbH Vollzeit

    Beruflicher HintergrundAls Regulatory Affairs Manager trägt unser Kandidat maßgeblich zur Umsetzung unserer strategischen Ziele in der pharmazeutischen Entwicklung bei. Er/ Sie ist für die Gewährleistung, dass regulatorische Vorgaben in die Erstellung und Einreichung von Unterlagen einfließen und dafür sorgt, dass lokale und globale Gesetze und...


  • Dresden, Sachsen, Deutschland Vality One Recruitment GmbH Vollzeit

    Dein AufgabengebietZuständigkeit für die Entwicklung und Durchführung von regulatorischen Anforderungen in der pharmazeutischen IndustrieÜberwachung und Gewährleistung, dass regulatorische Vorgaben in die Erstellung und Einreichung von Unterlagen einfließenBefolgung lokaler und globaler Gesetze und Richtlinien zur Zulassung von MedikamentenKooperation...


  • Dresden, Sachsen, Deutschland ROTOP Pharmaka GmbH Vollzeit

    Über unsMöchtest du Teil eines international agierenden Unternehmens in einer zukunftssicheren Branche werden? Wir bieten eine unbefristete Tätigkeit in einem modernen Arbeitsumfeld mitten im Grünen.Warum wir?Eine unbefristete Tätigkeit in einem international agierenden Unternehmen und einer zukunftssicheren Branche mit attraktivem Gehalt von mindestens...


  • Dresden, Sachsen, Deutschland Personalwerk Sourcing GmbH Vollzeit

    As a key member of our team at Personalwerk Sourcing GmbH, we are seeking an experienced Senior Corporate Legal Leader to oversee the legal strategy, operations, and risk management across our corporate functions.Key Responsibilities:Develop and execute the overall legal strategy for corporate functions, ensuring alignment with our business...


  • Dresden, Sachsen, Deutschland Personalwerk Sourcing GmbH Vollzeit

    Job Summary: As a key member of our team at Personalwerk Sourcing GmbH, the Head of Corporate Legal will play a crucial role in shaping the company's legal strategy and overseeing the legal operations across various corporate functions. The ideal candidate will possess a deep understanding of corporate governance, mergers and acquisitions, regulatory...


  • Dresden, Sachsen, Deutschland ConnCons GmbH Vollzeit

    Company OverviewConnCons GmbH is a rapidly growing startup dedicated to revolutionizing cancer therapy through cutting-edge technology. Our mission is to deliver data-driven solutions that enhance patient care, automate manual processes, and improve treatment efficiency.We strive to reduce the administrative burden on healthcare professionals by leveraging...