Regulatory Affairs Associate

vor 5 Monaten

Kundl, Österreich Sandoz Vollzeit

**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.

**What you’ll bring to the role**:
**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**:

- Experience in industry
- Knowledge of regulatory affairs basics

**Why Sandoz?**

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

The future is ours to shape

**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 € 43.548,40/year (on a full time basis). We also offer a potential market oriented excess payment in line with your experience and qualifications. We are open for part-time and job sharing models and support flexible and remote working where possible.

**Commitment to Diversity & Inclusion**:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here**:Job search | Sandoz**

**#Sandoz**

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