Head of Regulatory Affairs and Pharmacovigilance (m/f/d) - Pharmaceutical Industry (Hamburg Metropolitan Region)

Nordmark is one of the world's leading manufacturers of biological active ingredients and medicinal products in the Hamburg Metropolitan Region. Medium-sized and owner-managed, we offer our customers high-quality products and services: from the conduct of clinical studies, the development and formulation of medicinal products to production and quality control. More than 90 years of experience as well as our discovery and innovation driven spirit have made us an internationally valued partner.

Über uns

Nordmark ist einer der weltweit führenden Hersteller biologischer Wirkstoffe und Arzneimittel in der Metropolregion Hamburg. Mittelständisch geprägt und inhabergeführt bieten wir unseren anspruchsvollen Kunden hochwertige Produkte und Dienstleistungen von der Durchführung klinischer Studien über die Entwicklung und Formulierung von Arzneimitteln bis zur Produktion und Qualitätskontrolle. Mehr als 90 Jahre Erfahrung, Entdeckergeist und Innovation machen uns zu einem international geschätzten Partner.

Ihre Aufgaben

  • Organisation and management of the department "Regulatory Affairs and Pharmacovigilance" with responsibility for the areas of drug regulatory affairs, pharmacovigilance, regulatory compliance, literature and archives, as well as employee management and development (10 staff members)
  • Coordination and planning of projects and group-specific tasks, taking into account available resources and company goals
  • Developing regulatory strategies and dossiers, as well as submitting and maintaining national and international marketing authorisations
  • Establishing and maintaining contacts with regulatory authorities, as well as preparing and conducting authority meetings
  • Organising regulatory support of customers
  • Establishing, operating and developing structures and systems for pharmacovigilance, regulatory compliance as well as literature and archive management

Ihr Profil

  • Degree in pharmaceutical or natural sciences (University or University of Applied Science), at least 5 years of professional experience in regulatory affairs, preferably in an international environment
  • Knowledge of the relevant regulations in the field of regulatory affairs and pharmacovigilance
  • Leadership experience and/or experience in the coordination of project teams
  • Independent, reliable and structured way of working
  • Skills in leadership, communication, teamwork and organisation, high flexibility
  • Very good knowledge of German and English, both in written and spoken
  • Very good knowledge of MS-Word, MS-Excel as well as databases (e.g. Access, drugTrack, xEVMPD)

Wir bieten

  • An attractive workplace with a high level of responsibility
  • A performance-related payment
  • Development and qualification opportunities
  • Financial employee profit sharing scheme 
  • Numerous above-average company and collectively agreed social benefits
  • A wide range of offers for health maintenance and work-life balance
  • Mobile working

You identify with this position and are excited about your new challenge?

Then we look forward to receiving your application via our application system, stating your salary requirements.

Kurzinfos

  • Kennziffer: AR_0521_1
  • Einsatzort: Uetersen
  • Position: Führungskräfte
  • Vertragsform: unbefristet
  • Arbeitszeit: Vollzeit

Ihr Ansprechpartner

Herr Janssen

Einheit Personal
Kennziffer: AR_0521_1

personalabteilung@nordmark-pharma.de

Nordmark Pharma GmbH, Pinnauallee 4, 25436 Uetersen