Group Regulatory Affairs Manager (m/f/d)
Group Regulatory Affairs Manager (m/f/d)
Group Regulatory Affairs Manager (m/f/d)
Group Regulatory Affairs Manager (m/f/d)
Octapharma Pharmazeutika Produktionsges.m.b.H.
Pharmazeutische Produkte, Arzneimittel
Austria
- Art der Anstellung: Vollzeit
- 51.000 € – 78.500 € (von XING geschätzt)
- Vor Ort
- Aktiv auf der Suche
Group Regulatory Affairs Manager (m/f/d)
Über diesen Job
Group Regulatory Affairs Manager (m/f/d)
Octapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are now hiring for our team:
Group Regulatory Affairs Manager (m/f/d) – RIS
Job ID:
60629
Your new challenges which will inspire you:
- Leading regulatory IT projects including software upgrades, and identification and implementation of new solutions
- Technical maintenance and support of regulatory IT systems (e.g. regulatory database, publishing software, validation tools) including user training and assistance
-
Acting as primary interface between the Regulatory Affairs department and IT
Monitoring and implementing authority-specific regulatory IT systems (e.g. submission portals, HC-REP, SPL, EMA IT systems) - Staying informed and implementing of technical regulatory requirements (e.g. eCTD 4.0, ePI, eAF, pilot projects with authorities, onboarding of new countries to eCTD)
- Ensuring compliance with internal SOPs and applicable regulations through the regular review and application of relevant directives
- Performing data compliance checks to ensure adherence to SOPs and local regulations
- Preparation of registration dossiers and maintaining accurate product records in the registration database
Your profile that will convince us:
- Completed University degree in natural sciences (or related)
- 3-5 years working experience in Regulatory Affairs, Regulatory Affairs IT or Regulatory Compliance
- Project management skills are beneficial
- Very good communication skills in Business English, German is a plus
- Strong problem-solving and analytical skills as well as organizational strength
- Technically proficient, with experience using databases, document processing tools, spread-sheets, and emerging digital solutions such as AI
- Able to work in a team environment with shifting priorities and requirements
Our attractive benefits for you:
- Wide range of tasks in an international setting, flexibility and personal responsibility
- Reliable employer with generous employee benefits and a salary customary in the market
- Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant, extraordinary staff events and many more:
Additional information:
The minimum gross wage according to the collective agreement (chemical industry) for your new job is EUR 4.270,14. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay wages higher than collectively agreed.
We are looking forward to new, committed employees who join forces with us to promote our strong growth in order to keep enabling our patients to live a better life – because it is in our blood! Is it in your blood too? We are looking forward to receiving your application via our online career portal.
Gehalts-Prognose
Unternehmens-Details
Bewertung von Mitarbeitenden
Gesamtbewertung
Basierend auf 361 BewertungenVorteile für Mitarbeitende
Flexible Arbeitszeiten
Kantine
Betriebliche Altersvorsorge
Barrierefreiheit
Gesundheitsmaßnahmen
Betriebsarzt
Training
Parkplatz
Günstige Anbindung
Vorteile für Mitarbeitende
Smartphone
Gewinnbeteiligung
Veranstaltungen
Unternehmenskultur
Unternehmenskultur
361 Mitarbeitende haben abgestimmt: Sie bewerten die Unternehmenskultur bei Octapharma Pharmazeutika Produktionsges.m.b.H. als traditionell. Der Branchen-Durchschnitt tendiert übrigens leicht in Richtung modern