Job ID293390BRPosition TitleRegulatory Affairs ManagerApply to Job
Job Description
80! countries worldwide refer to the Novartis marketing authorizations for innovative drugs and therapies in Switzerland. As a member of the Swiss Regulatory Affairs team within the Global Drug Development, you play a key role to ensure patient access to innovative treatments!
Your responsibilities will include:
• Works closely with global and local colleagues from drug regulatory affairs (DRA) and other line functions to advise and agree on local regulatory strategy and drive the implementation thereof. Participates actively in local cross-functional brand teams and global DRA subteams.
• Critically evaluates and discusses regulatory strategy, timelines, data and rationale with local and global teams to ensure timely approvals of new marketing authorizations, and life-cycle related applications for marketed drugs
• Proactively establishes and maintains contacts to health authority partners. Organizes and participates in Swissmedic meetings to support product development programs
• Ensures that submissions to health authority are made in accordance with Swissmedic regulatory standards within appropriate timeframes, including PSURs, DSURs and RMPs, notifications on marketing and de-registration status of registered products. In case of transfers of Marketing Authorizations to another entity or third party supports transfer application and manages transfer of regulatory dossier
• Builds and maintains the Swiss-specific parts of regulatory dossiers including Information for Professionals and Patient and Packaging Information as well as National Succinct Statement. In close collaboration with other line functions ensure efficient launch preparation for new products
• Monitors and manages an efficient assessment process to expedite and optimize the outcome of the submissions. When appropriate, conducts negotiations with Swissmedic to ensure efficient product labelling. Coordinates and prepares answers to questions raised by Swissmedic, either related to submissions or ad hoc on topics, ensuring involvement of local and global partners
• Ensures accurate archiving of all documents submitted to and received from Swissmedic, ensures accurate and timely data update of regulatory compliance databases (DRAGON and REDI/REDI-GO) for assigned products
Minimum requirements
• Advanced degree in Pharmacy or Life Sciences or other relevant education
• At least 2-3 years of experience in regulatory affairs or drug development in the pharmaceutical Industry
799 million. That’s how many lives our products touched in 2019. 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.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: talentnetwork.novartis.com/networkDivisionGlobal Drug DevelopmentBusiness UnitREG AFFAIRS GDDLocationSwitzerlandSiteRotkreuzCompany/Legal EntityNovartis Pharma Schweiz AGFunctional AreaResearch & DevelopmentJob TypeFull TimeEmployment TypeRegularShift WorkNo
