Technical Drug Regulatory Affairs Manager (m/f)

REFERENZNUMMER:

328550/11

IHRE AUFGABEN:

-Represent the technical regulatory function in cross-functional teams with respect to drug and device combination products
-Provide strategic leadership and regulatory guidance for the teams/functions on technical regulatory drug and device combination product issues
-Successfully negotiate technical regulatory plans
-Manage the generation of high quality global regulatory submissions for clinical trials and marketing authorization applications in collaboration with other disciplines
-Regulatory applications and submissions, planning of regulatory strategies, assessing regulatory compliance and supporting quality systems

IHRE QUALIFIKATIONEN:

-University degree (Master or PhD) in a scientific discipline
-Knowledge in biotechnology as well as drug and device combination product experience
-Expert knowledge and experience in regulatory, and drug and device combination product
-Excellent communication, collaboration, and interpersonal skills
-Effective problem solving and strong organizational skills, including ability to prioritize tasks

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager