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Doing now what patients need next. This is what drives us everywhere at Roche to achieve better outcomes for more patients faster.
As the Drug Regulatory Manager you will work at Roche Pharma (Switzerland) AG, the Swiss affiliate of the Roche Group based in Basel-Stadt. We are a team of ca. 180 employees and cover Registration, Market Access & Health Care Affairs, Medical Affairs, Marketing & Sales, Governmental Affairs and Quality Assurance for the pharmaceuticals of Roche in Switzerland.
Our performance-oriented entrepreneurial employees work every day to make our innovative medicines and services available for patients in Switzerland.
As Drug Regulatory Manager you are responsible for ...
In this position you will:
Compile and submit dossiers (NDA and variations) to obtain and maintain Swiss registrations for new and branded products in diverse therapeutic areas of Roche
Be responsible for regulatory compliance of dedicated product portfolio
Support safety-relevant activities and submit DHPC, RMP, PBRER
Manage communication with Swissmedic and interact intensively with internal (affiliate and headquarters) stakeholders and external vendors
Inform and consult other departments within the affiliate and global on regulatory strategy, variations and regulatory requirements
Analyse and implement the changing Swissmedic requirements
Monitor and proactively fulfill timelines of the agency and other working partners
Coordinate the implementation of the approved variations locally and with global stakeholders
Master's Degree/PhD in science or healthcare discipline, pharmacy or human medicine preferred
At least 3 years of experience in drug regulatory affairs, preferably at least 2 years of experience in Swiss regulations and with Swissmedic. Experience with NDA submissions is an asset.
E xperience with medical device regulation is an asset
Strategic thinker and proactive behavior
Good communicator with strong ability to prioritize according to timelines and business needs
Successful cross-functional team player but also able to work independently
Ability to work within tight timelines with very good project management skills
Fluent in German and English, French and Italian are an asset
Can-do attitude and compliance mindset
Were we able to raise your interest for this position? Then please submit your application directly here through Workday.
If you need further information, please feel free to contact Corinne Wenger, DRA Head (+ 41 61 715 43 41).
If you need further information, please feel free to use our FAQs and videos .
Wer wir sind Roche Pharma (Schweiz) AG mit Sitz in Reinach BL beschäftigt rund 150 Mitarbeitende in den Bereichen Marketing und Verkauf, klinische Forschung, Zulassungsgesuche, Marktzutritt, wissenschaftliche Dokumentation sowie medizinische Beratung. Mehr dazu .
Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.