Manager Regulatory Affairs

Vor 5 Tagen

Langkampfen T, Österreich Sandoz Vollzeit

**Manager Regulatory Affairs (f/m/d), Schaftenau/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.**Your key responsibilities**:

- 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

**Commitment to Diversity & Inclusion**:

- Novartis is 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**:

- 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 Novartis?**

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
- We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
- We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
- **Imagine what you could do here at Novartis
**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 within the Novartis group. 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 € 64.788,30/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.**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
- Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.**Division**
- SANDOZ

**Business Unit**
- BioPharma SZ

**Country**
- Austria

**Work Location**
- Schaftenau

**Company/Legal Entity**
- Sandoz GmbH

**Functional Area**
- Research & Development

**Job Type**
- Full Time

**Employment Type**
- Regular

**Shift Work**
- No

**Early Talent**
- No

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