Manager Regulatory Affairs

vor 5 Monaten

Kundl, Österreich Sandoz GmbH Vollzeit

**Manager Regulatory Affairs (d/f/m), Kundl, Tyrol, Austria**

8 This is the number of high-quality biosimilars for which Sandoz has already received a marketing authorization, and that provided increased access to life-saving medicines to patients worldwide. Additionally, Sandoz has a rich pipeline of further biosimilars under development. As a Manager Regulatory Affairs (d/f/m) you provide strategic regulatory input and support for maintaining marketing authorizations worldwide and for initial submissions of biosimilar products in designated countries You are interested in gaining regulatory knowledge while bringing along a collaborative and patient-focused mind-set.

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

**Your key responsibilities**:
Your responsibilities include, but are not limited to:

- Identify potential regulatory gaps besides providing risk mitigation and minimization measures during strategic evaluations
- Provide input and collaborate with partners about implementing strategies, ensuring timelines and requirements, or assuring congruency and compliance
- Take over the regulatory lead for defined project tasks.
- Act as representative of regulatory functions in cross-functional project teams and workstreams
- Own the preparation of responses to regulatory relevant queries from various partners and directly interact with regulatory authorities and/or with regulatory functions in the countries

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

Minimum Requirements

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

- University degree in natural sciences, ideally PhD, or comparable qualification
- Minimum of two years of work experience in pharmaceutical or biotech regulatory affairs
- Proficient in English (oral and written)
- Strong communication, negotiation, and interpersonal skills
- Ability to work in interdisciplinary teams
- Ability to work in a matrix environment
- Ability to interpret scientific data and to construct persuasive regulatory documents

**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 € 60,212.18/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are open for part-time and job sharing models and support flexible and remote working where possible.

Sandoz
- Division
- SANDOZ
- Business Unit
- Sandoz Global Development
- Location
- Austria
- Site
- Kundl
- Company/Legal Entity
- Sandoz GmbH
- Functional Area
- Research & Development
- Job Type
- Full Time
- Employment Type
- Regular
- Shift Work
- No

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