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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 (m/f/d) 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.
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:
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 (m/f/d) 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.
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:
- Evaluate regulatory requirements and provide regulatory strategies when preparing or managing the timely delivery of high quality documentation required for initial marketing authorization applications and dossier updates worldwide
- 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:
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:
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
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?
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
Division
SANDOZ
Business Unit
Sandoz Global Development
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
Yes
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