Senior Manager Regulatory Affairs (m/f/d)

The Senior Manager Regulatory Affairs (m/f/d) is part of the International Regulatory Affairs Team in the Business Unit Parenteral Nutrition, Keto-Analogues & Standard I.V. Fluids of the Pharmaceuticals & Devices Division. He/she is responsible and has a leading regulatory function for both submission and strategy, i.e. preparation, receipt, maintenance and submission of regulatory filings for the Standard I.V. Fluids/Colloids portfolio worldwide and has to ensure that these are in accordance with respective regulatory requirements.

  • Responsible for ensuring that regulatory strategies and regulatory activities are efficiently executed to meet the legal requirements and business objectives
  • Provide global regulatory strategies for new submissions/developments and maintenance projects
  • Timely and high-quality preparation, review and collection of submission documentation in collaboration with other departments
  • Maintaining existing drug approvals (renewal and variation procedures)
  • Support in preparation of clinical trial applications and amendments for clinical studies to authorities in EU
  • Actively participate and represent Regulatory Affairs in project teams to ensure all regulatory requirements are met throughout the development process
  • Identification and control of external service providers for regulatory support (CROs)
  • Provide responses to deficiencies letters from authorities within the approval procedures
  • Building strong relationships and collaborating with responsible regulatory authorities
  • Collaborate with and support regional and national Drug Regulatory Affairs teams
  • Maintain the regulatory database
  • Creation and processing of documents in the company's own Document Management System
  • Creation of electronic submissions (eCTD, NeeS)
  • Successfully completed university degree (Bachelor or Master) in Pharmacy, Biology, Chemistry or higher in relevant field
  • 6 + years of professional experience in Drug Regulatory Affairs, especially the EU regulatory requirements, in an international environment
  • Understanding of global regulations
  • Good knowledge in working with document management systems, publishing tools and databases for regulatory purposes
  • Personal integrity and reliability
  • Organizational talent with sense of responsibility and flexibility
  • High carefulness and accuracy in the way of working
  • Experience in working with interdisciplinary, multinational and virtual teams
  • Strong communication skills
  • Very good skills in MS Office (Excel, PowerPoint, Word, Outlook)
  • Fluent in English and German, any other language would be beneficial
  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Regulatory Affairs / Drug Safety
  • Arbeitsverhältnis:
  • Unbefristet / Vollzeit
  • Unternehmensbereich:
  • Fresenius Kabi
  • Standort:
  • Hessen / Bad Homburg
  • Bewerbungsfrist:
  • none - we look forward to your application

Ihre Benefits

  • 05_Langzeitkonto
Erfahren Sie mehr über unser Angebot
Katharina Weißbrodt
Fresenius Kabi Deutschland GmbH
Oberursel
Ref. number: 42577

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

Senior Manager Regulatory Affairs (m/f/d)

The Senior Manager Regulatory Affairs (m/f/d) is part of the International Regulatory Affairs Team in the Business Unit Parenteral Nutrition, Keto-Analogues & Standard I.V. Fluids of the Pharmaceuticals & Devices Division. He/she is responsible and has a leading regulatory function for both submission and strategy, i.e. preparation, receipt, maintenance and submission of regulatory filings for the Standard I.V. Fluids/Colloids portfolio worldwide and has to ensure that these are in accordance with respective regulatory requirements.

Your assignments

  • Responsible for ensuring that regulatory strategies and regulatory activities are efficiently executed to meet the legal requirements and business objectives
  • Provide global regulatory strategies for new submissions/developments and maintenance projects
  • Timely and high-quality preparation, review and collection of submission documentation in collaboration with other departments
  • Maintaining existing drug approvals (renewal and variation procedures)
  • Support in preparation of clinical trial applications and amendments for clinical studies to authorities in EU
  • Actively participate and represent Regulatory Affairs in project teams to ensure all regulatory requirements are met throughout the development process
  • Identification and control of external service providers for regulatory support (CROs)
  • Provide responses to deficiencies letters from authorities within the approval procedures
  • Building strong relationships and collaborating with responsible regulatory authorities
  • Collaborate with and support regional and national Drug Regulatory Affairs teams
  • Maintain the regulatory database
  • Creation and processing of documents in the company's own Document Management System
  • Creation of electronic submissions (eCTD, NeeS)

Your profile

  • Successfully completed university degree (Bachelor or Master) in Pharmacy, Biology, Chemistry or higher in relevant field
  • 6 + years of professional experience in Drug Regulatory Affairs, especially the EU regulatory requirements, in an international environment
  • Understanding of global regulations
  • Good knowledge in working with document management systems, publishing tools and databases for regulatory purposes
  • Personal integrity and reliability
  • Organizational talent with sense of responsibility and flexibility
  • High carefulness and accuracy in the way of working
  • Experience in working with interdisciplinary, multinational and virtual teams
  • Strong communication skills
  • Very good skills in MS Office (Excel, PowerPoint, Word, Outlook)
  • Fluent in English and German, any other language would be beneficial

Ihre Benefits

  • 05_Langzeitkonto
Erfahren Sie mehr über unser Angebot

Ihr Kontakt

Katharina Weißbrodt
Fresenius Kabi Deutschland GmbH
Oberursel
Ref. number: 42577

Karrierelevel
Berufserfahrene
Einsatzbereich
Regulatory Affairs / Drug Safety
Arbeitsverhältnis
Unbefristet / Vollzeit
Unternehmensbereich
Fresenius Kabi
Standort
Hessen / Bad Homburg
Bewerbungsfrist
none - we look forward to your application

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

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