Global Program Regulatory Manager (m/f)

REFERENZNUMMER:

366321/29

IHRE AUFGABEN:

-Support the team in planning and tracking meetings and deliverables to support regulatory submissions
-Support regulatory Lead in the preparation and submission of global original Clinical Trial Applications (CTA)
-Independently prepare maintenance regulatory submission packages such as substantial amendments, DSURs, investigator brochures, clinical study reports etc.
-Support the coordination of teams in the preparation of health authorities responses to submissions
-Interpret and understand regulatory implication of non-clinical and clinical data
-Provide strategic regulatory input into selected clinical trials documents such as protocols, IBs, DSURs

IHRE QUALIFIKATIONEN:

-Science based BSc or MSc
-Excellent project management skills with proven ability to manage several projects and competing priorities
-Strong interpersonal, communication, negotiation and problem solving skills
-Fluency in English (written and spoken)
-Profound regulatory experience, including proven experience in planning and compilation of CTAs with special focus on European submissions, including addressing Health Authorities questions
-Experience with small molecules and biologicals and the review/approval process in Asia is an additional asset
-Regulatory operational expertise
-Working in a global/matrix environment or cross-functional teams

WEITERE QUALIFIKATIONEN:

Clinical project manager