PTA as Regulatory Affairs Manager (m/f/d)

Das ist der Job

CTA, PTA, BTA) Approximately 3 years professional workin

Darum lohnt es sich

Specialist Global Regulatory Affairs Mainz, Germany | full time | Job ID:9339 You will support the Global Regulatory Affairs (GRA) Development Pipeline team in the planning, preparation, and recording of regulatory submissions.

Prepare regulatory documentation in close cooperation with the GRL and GRA internal and external stakeholders for all regulatory submissions managed by the GRA Development Pipeline team Ensure good documentation practice Coordinate provision of requests from local regulatory partners to the responsible internal functions Support preparation of responses to health authority inquiries Track regulatory activities, enter and maintain data in respective databases for regulatory status, planning activities, and publishing Support GRA process documentation activities and contribute to the improvement of internal GRA processes May prepare and update presentations in close cooperation with the GRL Support regulatory meetings as needed (e.g. schedules meetings, prepares minutes) Professional training or degree in the technical, commercial or pharmaceutical field, or equivalent experience (e.g.

In your role you will closely work with the Global Regulatory Leads (GRLs) in managing clinical trials and product development from a regulatory perspective. Moreover, you may act as the primary contact for local regulatory partners or collaborators (e.g. license partners, affiliates, local regulatory vendors, CROs).