Regulatory affairs manager sandoz development center

Novartis pharma gmbh

• Rudolstadt

neues Angebot (12/03/2020)

stellenbeschreibung

Job Description 15 millions in more than 50 countries. So many units manufactured are available for patients of respiratory diseases per year. Aeropharm GmbH is the Sandoz Excellence Centre for the development of respiratory products. As Regulatory Affairs Manager (w/m/d), you will be member of the expert project team responsible for the documentation of MAAs (CTD-Module 2-5) and you will coordinate the regulatory matrix team for your assigned products

Your Main Tasks

:

• providing regulatory input for our inhalation products - preparing submissions for marketing authorizations applications for global markets and represent the inhalation development projects at health authority meetings - defining and preparing the module 2 to 5 content (data and documentation) for regulatory submissions and review with established guidelines - coordinating other professionals within the regulatory network - keeping project team colleagues and relevant stakeholders up to date minimum requirements minimum requirements:
• a degree (minimum bsc) in a life sciences or pharmacy related subject - understanding of global regulatory requirements and critical evaluation of emerging requirements - working knowledge in preparation of impds and ctd documentation for ma applications - working knowledge of the drug development process - fluent in english, german of advantage - experience in regulatory affairs within the pharmaceutical industry advantageous - good communication- and negotiation skills - problem-solving ability, flexibility and teamwork why consider novartis? 750 million. that's how many lives our products touched in 2018. 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 are novartis. join us and help reimagine medicine. we develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples' lives. we do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity. novartis stands up for equal opportunities and for the integration of persons with disabilities. hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability. division sandoz business unit product dev sz location germany site rudolstadt company/legal entity aeropharm gmbh functional area research & development job type full time employment type regular shift work no

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