Regulatory Affairs and Medical Compliance Assistant (M/W/D) at AstraZeneca

Vienna, , Austria -

Full Time

Start Date

Immediate

Expiry Date

08 Jul, 26

Salary

46768.8

Posted On

09 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory affairs, Medical compliance, Sharepoint, Budget monitoring, Good regulatory practice, SOP maintenance, Business continuity planning, Archive management, Quality assurance, Due diligence, MS Office, Project management, Process management, Communication, Team interaction

Industry

Pharmaceutical Manufacturing

Description

General Job Responsibilities: Conducts activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Completes all required training on the AZ Code of Conduct and supporting Policies and Standards on time, reports any potential issues of non-compliance. Main tasks: Acts as a super user for the Regulatory Sharepoints (maintenance and further development). Prepares the Fachinformation, Gebrauchsinformation and Fachkurzinformation out of the approved text for the cross functional teams Handles and documents information on parallel imported products. Assists the RA team with generic administrative tasks incl. Purchase Orders and vendor management, meeting organisation, travel and training, etc. Supports the regulatory team in all activities related to budget monitoring and control. Supports the Regulatory team in all the activities related to the registration and maintenance of products, as well in GRP (Good Regulatory Practice), in compliance with all local and global codes, standards and procedures. Supports the maintenance/revision and creation of RA SOPs and the Business Continuity Plan (BCP). Organize the yearly testing of the BCP. Oversees, organises and manages the Regulatory Affairs digital and hardcopy archive, ensuring appropriate archiving according to the retention guideline (acts as the RA team Archive Coordinator). Supports the RA team and the Medical Team/Medical Director in the quality assurance and business compliance area (e.g. due diligence processes). Cooperation and mutually backing up with the Medical Affairs Assistant for essential tasks during planned and unplanned absences and workload, by regularly align and exchange to ensure a consistent way of working. Supports Compliance Business Partner with the Quarterly Compliance Monitoring activities for the MC. Education: Matura/ Abitur International baccalaureate or equivalent education Working Knowledge/Experience: At least 3 years’ proven professional experience in industry, preferably in the pharmaceutical sector, or in the healthcare sector Command in English and German (written and spoken) Functional skills/ competencies Agile thinking paired with pragmatic approach Efficient, meticulous and self-motivated way of working Project and process management experience Strong organisational skills with oversight and ability to manage complexity under set timelines Strong willingness to learn Soft skills & Technical competencies Proficient MS Office Ability to work with new technologies Brings innovative and creative ideas within a regulated setting Strong interpersonal and team interaction skills We offer: Base salary: €46,768.80 per year (full-time basis) Bonus opportunities depending on company performance Comprehensive social benefits, including company pension scheme and supplementary insurance Flexible working hours with hybrid work models Support for continuous professional development The opportunity to work in an environmentally conscious company aiming to be climate neutral by 2025 Why AstraZeneca? Become part of AstraZeneca’s journey to bring life‑saving medicines to patients around the world. We are driven by the solutions we create for the healthcare ecosystem and achieve measurable impact across the entire patient journey. Our team thrives on energy and pace, embraces opportunities for innovation and experimentation, and always acts with a patient‑centric focus. Together, we actively contribute to lowering the global mortality curve. With us, you will find numerous opportunities to develop your career alongside top‑class talent. Date Posted 09-Apr-2026 Closing Date AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.

Responsibilities

The role involves supporting the regulatory affairs team with product registration, maintenance, budget monitoring, and documentation management. Additionally, the assistant will coordinate digital and hardcopy archives and assist in quality assurance and compliance monitoring activities.