Drug Regulatory Manager (2 years, 100%)

Job description

  Job facts

Roche Pharma Switzerland is an important partner in the Swiss healthcare system and covers marketing & sales, medical affairs, regulatory affairs, market access, reimbursement and quality assurance for Roche medicines in Switzerland. Roche Pharmaceuticals Switzerland has been based in Reinach, BL since 1992 and has around 170 employees.

To reinforce our Drug Regulatory Affairs (DRA) department, we are looking for a Drug Regulatory Manager (2 years, 100%).

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

Requirements:

·  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.
·  Experience 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

If you need further information, please feel free to contact Corinne Wenger, DRA Head () or Christine Müller, HR Business Partner (). Please submit your application directly through Workday.

·  Who we are

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.