Senior Regulatory Affairs Manager (f/m/d)
- Employer
- Novartis
- Location
- Kundl, Austria
- Salary
- Competitive
- Closing date
- Jun 7, 2023
View more
- Sector
- Pharmaceutical, Regulatory Affairs
- Hours
- Full Time
- Organization Type
- Corporate
- Jobseeker Type
- Professional
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Job Description
Senior Regulatory Affairs Manager (f/m/d), Kundl, Austria
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz... are you ready to make a difference?
Your key responsibilities:
Your responsibilities include, but are not limited to:
• 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.
• Formulate and lead global regulatory submission strategies and preparation and submission of high-quality registration documents for active ingredients
• Supervise and develop associates regarding regulatory landscape
• Active monitoring of scientific literature and new guidelines in the regulatory field
Diversity & Inclusion / EEO
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 5-8 years of experience in pharmaceutical or chemical industry in a similar role
• Masters degree or higher in natural science
• Broad knowledge of regulatory guidelines
• Good knowledge of relevant software tools
Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
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.
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: https://talentnetwork.novartis.com/sandoztalentpool
#Sandoz
Senior Regulatory Affairs Manager (f/m/d), Kundl, Austria
2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, purpose-driven organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally!
Together we will shape the future of Sandoz... are you ready to make a difference?
Your key responsibilities:
Your responsibilities include, but are not limited to:
• 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.
• Formulate and lead global regulatory submission strategies and preparation and submission of high-quality registration documents for active ingredients
• Supervise and develop associates regarding regulatory landscape
• Active monitoring of scientific literature and new guidelines in the regulatory field
Diversity & Inclusion / EEO
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 5-8 years of experience in pharmaceutical or chemical industry in a similar role
• Masters degree or higher in natural science
• Broad knowledge of regulatory guidelines
• Good knowledge of relevant software tools
Why Sandoz?
Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
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.
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: https://talentnetwork.novartis.com/sandoztalentpool
#Sandoz
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