Regulatory Affairs Manager - Kundl, Österreich - Sandoz
Beschreibung
Regulatory Affairs Manager (f/m/d), Kundl/Tirol, Austria
500 million That is how many patients we reach with our products every year, improving their lives. It is our aim to expand this to more than 1 billion.
Sandoz, a division of Novartis, is a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.
Your key responsibilities:
- Regulatory evaluation and critical assessment of suitability of regulatory documentation and approaches of external suppliers of active ingredients in regard to nitrosamines and mutagenic impurities in line with ICH M7 guideline and other applicable regulations.
- Actively monitoring of scientific literature and new guidelines in the regulatory field.
- Regulatory evaluation of change requests
- Preparation, submission and maintenance of highquality registration documents for active ingredients
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:
- Minimum of 3 years of experience in pharmaceutical or chemical industry in a similar role
- Bachelor or Masters degree in natural science
- Broad knowledge of regulatory guidelines
- Good knowledge of relevant software tools
- Aim for eight bullet points
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 groundbreaking 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 In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement.
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
- Product Dev SZ
Country
- Austria
Work Location
- Kundl
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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