Job Description Are you interested to learn more about Regulatory Affairs (RA) and the pharmaceutical industry? After your Master’s, Doctoral or Post-doctoral qualification, do you want a career in Regulatory Affairs? Do you have a collaborative mindset and take ownership of assigned tasks? Are you able to quickly adapt to different teams and concepts, with excellent problem solving skills? Would you like to work and gain experience in a cross-functional team in the multicultural and diverse environment of a global healthcare leading company? The Regulatory Affairs Postgraduate Training Program is an opportunity to discover the global functions of Regulatory Affairs and Regulatory Chemistry, Manufacturing and Controls. Successful candidates will be offered a training position consisting of two rotational assignments, each of 1 year duration, within two different RA functions.
Responsibilities could include, but are not limited to:
• Interacting with global interdisciplinary project teams to provide strategic regulatory input to development, submission planning, including documentation needed, as well as timelines and strategic risks • Supporting and/or preparing high quality dossiers, drug substance and/or drug product quality documentation to support global regulatory submissions (e.g. Clinical Trial Applications, Market Authorization Applications, post-approval variations etc.) • Supporting and/or preparing high quality dossiers according to specific requirements in the different countries and regions • Supporting submission and response activities (planning, preparation, review, coordination, submission) • Ensuring regulatory compliance by creating awareness of requirements and guidelines, facilitating timely submission of variations and participation in the change control process • Supporting the development and maintenance of globally consistent product information • Supporting Regulatory Intelligence group and coordinating on gathering Line Functions comments on draft regulatory guidelines and legal framework • Monitoring, searching for and evaluating legislation, as well as guidelines from different sources
Duration and start of training: 2 years with an expected start date in January 2021
• Strong interest in Regulatory Affairs and Drug Development • Completion of an MSc, PhD or Post-doctoral qualification in Pharmaceutical Sciences/Pharmacy/Life Science or equivalent and in Regulatory Affairs (desirable) within the last 18 months; • Fluency in English; • Ready to expand your knowledge and are open minded with an international outlook • Strong interpersonal skills i.e. can demonstrate your ability to communicate well with people from a variety of backgrounds/cultures and at different hierarchical levels inside and outside the company
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 empowered to ask new questions, make bolder decisions and take smarter risks.
We are Novartis. Join us and help us reimagine medicine.
Novartis is an equal opportunity employer committed to embracing and leveraging diverse backgrounds.
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