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

Octapharma Pharmazeutika Produktionsges.m.b.H.

Pharmazeutische Produkte, Arzneimittel

1.001-5.000 Mitarbeitende

Wien, Österreich

Bewertung von Mitarbeitenden

Gesamtbewertung

3.3

Basierend auf 359 Bewertungen

Vorteile für Mitarbeitende

Flexible Arbeitszeiten

Kantine

Betriebliche Altersvorsorge

Barrierefreiheit

Gesundheitsmaßnahmen

Betriebsarzt

Training

Parkplatz

Günstige Anbindung

Vorteile für Mitarbeitende

Smartphone

Gewinnbeteiligung

Veranstaltungen

Unternehmenskultur

359 Mitarbeitende haben abgestimmt: Sie bewerten die Unternehmenskultur bei Octapharma Pharmazeutika Produktionsges.m.b.H. als traditionell.Der Branchen-Durchschnitt geht übrigens leicht in Richtung modern

Mehr Infos anzeigen

Group Regulatory Affairs Manager (m/f/d)