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

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

Job-ID : 60629

Location : Wien, AUT

Job Level : Professionals

Category : Regulatory Affairs

Employment Type : Permanent position

Become part of a vital chain and contribute to our common goal of making people's lives better. Octapharma is a leading biotech pharmaceutical company that combines the strength of a global organisation with the values of a family business. We specialize in the development and manufacture of high-quality pharmaceuticals derived from human blood plasma and human cell lines.

With over 1,600 employees, the Octapharma site in Vienna is the largest production site, and successful research and development location.

Join us in shaping our vision of providing new health solutions advancing human life.

Your main tasks and responsibilities

• 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 expertise and ideal skill set

Your department - where you make an impact

Thrive with us

Enjoy these attractive benefits! You can find all offers here : Benefits

The minimum gross salary according to the collective agreement (chemical industry) is EUR 4,270.14 based on 38 hours per week (full-time). As we strive to offer a salary that reflects your individual profile and qualifications, there is a willingness to pay above the minimum salary.

Its in our blood

We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.

Do you have any questions? Then get in touch with your contact person.

Mrs. Johanna Proksch

Octapharma Pharmazeutika Produktionsges.m.b.H.

Oberlaaer Straße 235, 1100 Wien

T : +43 (1) 610 32 4299

You can also reach us Monday to Friday via WhatsApp : +43 (0) 664 885 78 113

Want to find out more about us?

Visit our website Octapharma Career and follow us daily on LinkedIn.

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