Associate Regulatory Affairs limited for 2 years (d/f/m)

at  Sandoz

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!

ESSENTIAL REQUIREMENTS:

• Minimum Matura / Gymnasium / High School degree
• Strong interpersonal and communication skills
• Ability to work effectively in a matrix environment in a multi-cultural setting
• Ability to plan and prioritize workload
• Ability to work in a team
• High accountability to independently complete tasks
• Proficient in English (oral and written)

DESIRABLE REQUIREMENTS:

• Past experience in industry
• Basic knowledge of regulatory affairs

YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but are not limited to:

• Support activities and documentation necessary for Biosimilars submissions and product maintenance worldwide throughout lifecycle of the product (incl. variations, renewals, Periodic Safety Update Reports).
• Manage the interaction with DRA colleagues in country organizations (COs) and with Sandoz agents where no CO exists
• Support implementation of prompt and complete responses to regulatory relevant queries from various stakeholders (e.g. Health Authorities, COs).
• Support regulatory compliance activities, including operational support of relevant IT systems or databases.

IMAGINE WHAT YOU COULD DO HERE AT SANDOZ!

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 46.305,00/year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications.