Group Regulatory Affairs Manager (m/f/d) - RIS

Job-ID: 60629
Location: Wien, AUT
Job Level: Professionals
Category: Regulatory Affairs
Employment Type: Permanent position

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:

Your new challenges which will inspire you: 

• Leading regulatory IT projects including software upgrades, and identification and implementa-tion 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

• Leading regulatory IT projects including software upgrades, and identification and implementa-tion 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
  • Excellent English- and 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

• Completed University degree in natural sciences (or related)
  • 3-5 years working experience in Regulatory Affairs, Regulatory Affairs IT or Regulatory Compliance
  • Excellent English- and 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.

Your contact:

Johanna Proksch
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien,
T: +43 (1) 610 32 - 4299

About Octapharma

Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 195 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.

Apply now