Specialist Regulatory Affairs (m/f/d)

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

We are continually striving to improve the understanding of health care within the local community. Our site in 1100 Vienna (ICON TOWER) is a strategic location for the distribution of our high quality and innovative health care products, as well as digitally integrated solutions for our patients and clients. To ensure sustainable company growth, we continually aim to offer attractive career opportunities for more than 170 employees at our Vienna site.

Specialist Regulatory Affairs (m/f/d)

Responsibilities

Operational component

• Ensuring Life-cycle maintenance of assigned, authorized products.
• Taking part in subsidiary product and launch teams to provide regulatory input and strategic advice.
• Participating in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.
• Working in and with different databases.

Strategic component

• Providing guidance on pertinent EU and local regulations and guidelines. Collecting relevant public available regulatory information (regulatory intelligence) and informing relevant stakeholders.
• Maintaining a close relationship with internal (sub-regional, regional, global) and external regulatory contacts.
• Adequately supporting other functions to enable compliance in areas related to regulatory.

Qualifications

• Post-secondary education in scientific science or equivalent
• Excellent skills and knowledge of local and EU medicines legislation and regulatory procedures
• IT-skills with regard to word-processing, spreadsheets and database applications strongly required
• Good medical and scientific understanding and knowledge
• Solid experience in a Registration Department or equivalent dealing with most aspects of registration
• Ability to plan and prioritize regulatory tasks to meet company and local objectives
• Good interpersonal and managerial skills, capability of problem resolution, strategic thinking and the ability to work in a team environment
• Commitment, dedication to quality and the ability to handle multiple priorities simultaneously is a key condition
• Fluent in German and business proficient in English

We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 48.600,- (based on fulltime employment) and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

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