Sr Director, Regulatory Affairs

Gilead Sciences, Inc.

Später bewerben

We're looking for a candidate to fill this position in an exciting company.

  • Clinical trial applications, amendments and other clinical trial submissions
  • Compassionate Use & Early Access applications
  • Local Registration activities (mainly Variations for national approved products and translation for centralized approved products)
  • Risk minimization activities materials
  • Health care professional communication
  • Review and approval of promotional materials
  • Lead the creation, maintenance, training, evaluation and tracking of all local regulatory owned procedural documents including policies, SOPs, manuals and working instructions that are needed locally to fulfil regulatory obligations

  • Extensive experience in and understanding of role of RA and regulatory requirements in Pharmaceutical / Biotech Industry including ICH obligations and understanding of current trends in local and regional requirements
  • Very good influencing and negotiating skills. Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities
  • Demonstrates strong leadership skills with a sphere of influence externally, cross-functionally, within the RA function and in the affiliate
  • Previous people management experience and experience working directly with regulatory authorities
  • Excellent decision-making skills; makes important decisions that impact the department and ensures they are proactively and appropriately communicated
  • Excellent verbal, written, organization skills and interpersonal communication skills
  • Capacity to navigate himself/herself successfully within the Gilead matrix organization

Später bewerben

Stellenangebot in: München