Junior Regulatory Affairs Manager (m/f)

REFERENZNUMMER:

316086/11

IHRE AUFGABEN:

-Responsibility for designated regulatory projects and compliance with respective deadlines
-Submission of variations and maintenance of existing marketing authorization, mainly in the US and EU
-Interaction with Regulatory Affairs authorities, 3rd parties, US agents and distribution partners
-Interfacing with other departments on a national and international level
-Specialized tasks within the framework of Regulatory Affairs activities, e.g. support development projects with respect to regulatory requirements and responsibility for designated regulatory projects
-Administration of regulatory documentation and ensuring the traceability of regulatory history (filing, archiving, database etc.)

IHRE QUALIFIKATIONEN:

-University degree in life science (ideally in pharmaceutical sciences), or a medical degree
-Solid experience in Regulatory Affairs
-Good interpersonal, communication, negotiation and problem-solving skills
-Strong analytical skills
-Experience in working cross-functionally, experience in liaising with various stakeholders
-Fluency in English both in writing and speaking
-Strategic thinking and acting

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager