לוח אפשרויות קריירה - הדרך החכמה להייטק

The opportunity
This is a senior position within the regulatory team supporting the International Markets business unit. The individual will be responsible to lead and proactively manage a team of Regulatory   Managers who work on regulatory life cycle management activities for a mature innovator portfolio covering EU, US and other International Markets.   This is a leadership position that is accountable for hiring, training and retention of regulatory staff in the team in alignment with the objectives of the Global Regulatory Organization.  The Lead is also involved in continuous improvement and looking at new tools/technologies to improve efficiencies in ways of working.How you’ll spend your day
Accountable to support all activities related to Regulatory Life Cycle Management activities in Worldwide Markets (EU, US, Other Markets: CMC Variations, Renewals, PSUR, RMP, safety variations etc)
Hiring, Training and Retention of Staff in the team
Work closely with Worldwide markets, assesses dossier suitability and creates a submission tracker for all assigned products to ensure appropriate planning and prioritization.
Work closely with global regulatory teams in the EU/US/Other International Markets to support Life Cycle Management activities within Regulatory Affairs
Coordinate responses to Health Authorities, with appropriate personnel and departments to resolve outstanding regulatory issues.
Ensure that cross-functional activities to support submissions and works collaboratively with Market RA to ensure all requirements are met and dossiers are submitted as per the submission plan.
Establish vision for the team, team building activities, planning and prioritization of daily work and regular business updates to management.