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

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

• 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

Your department - where you make an impact

• We, the Regulatory Affairs department, are responsible for direct interactions with regulatory authorities worldwide and coordination with consultants. Our daily work includes preparing product dossiers in collaboration with other departments and submitting them to authorities, reviewing the content and format of submission documents, notifying authorities of changes and packaging materials, regularly updating the registration database, and using regulatory portals.

Thrive with us

• Company restaurant & meal subsidy
• Training & further education
• Health promotion
• Parking spaces and good public transport connections
• Company and team events
  
  

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.

It´s 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

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.