Regulatory Affairs Manager (BB-AC90D)
Gefunden in: Neuvoo CH
Job Description70! This is the number of countries that rely on our Swiss regulatory approvals for innovative products.
• Works closely with global and local colleagues from Regulatory Affairs (RA) and other relevant 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 RA sub-teams.
• 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 relevant contacts to health authority and other stakeholders. Where applicable 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.
• Creates 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 relevant line-functions ensure efficient launch preparation for new products.
• Monitors and ensures an efficient assessment process to expedite and optimize the outcome of the submissions. When appropriate, conducts negotiations with Swissmedic to ensure best possible product labelling. Coordinates and prepares answers to questions raised by Swissmedic, either related to ongoing submissions or ad hoc on specific topics, ensuring appropriate involvement of local and global stakeholders.
Minimum requirementsWhat you'll bring to the role:
• Advanced degree in Pharmacy or Life Sciences (Master) or other relevant education.
• Proficiency in German and English (oral and written), French is a plus
• 2+ years in regulatory affairs or drug development in the pharmaceutical industry
Why consider Novartis?
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.
*Some restrictions on flexible working options may apply and will be discussed during interview if applicable.
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:
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