Global Regulatory Affairs Project Manager (m/f)

REFERENZNUMMER:

254553/1

IHRE AUFGABEN:

-Manage the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentation at different Regulatory milestones
-Management of the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes (under supervision of a TA Head or Regulatory Strategist)
-Participate in regulatory strategies for projects (under supervision of the Regulatory Strategist )
-Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labelling) including CTAs

IHRE QUALIFIKATIONEN:

-Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
-Excellent spoken and written English
-Experience in Pharmaceutical industry and also Regulatory Affairs
-Experience in preparation and submission of a full submission or large variation/supplement in at least one ICH region through to authorization

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager