Regulatory CMC Senior Manager (m / f) - Biosimilars, Schaftenau, Austria
8! This is the number of biosimilars for which Sandoz, the global leader in biosimilars, has already received marketing authorization approval worldwide und thus has increased access to life-saving medicines.
Multiple additional biosimilars are in development. As senior manager, you independently provide strategic and operational global CMC regulatory direction and documentation for biopharmaceutical products covering development and post-approval activities.
You bring a foundation of regulatory knowledge regarding drug development, manufacturing, and analytical testing, as well as a collaborative and patient-focused mind-set.
Your Responsibilities :
Your responsibilities include, but not limited to :
Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements
What you’ll bring to the role :
Desirable requirements :
Contact : Jennifer Kriedemann, Talent Acquisition & Staffing Business Partner, +44 7525 702920
Why consider Novartis?
750 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this : how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment.
Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group.
The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 50,374.
38 per year on a full time basis).
We are Novartis. Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.