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Submission Planning and Execution Manager

vor 1 Woche


Basel, Basel-Stadt, Schweiz Novartis Farmacéutica Vollzeit
Position Summary

The Biomedical Research Submission Management, Associate Director will lead cross-functional submission sub-teams to project manage regulatory submissions. This role requires a strong understanding of regulatory requirements and experience in project management.

About the Role
  • Manage local submission management teams.
  • Prepare BR submission components including NDA and MAA dossiers.
  • Develop strategic submission plans and execute them.
  • Provide data visuals and monitor critical path activities.
Main Responsibilities:
  1. Manage local submission management team.
  2. Oversee preparation of BR submission components including NAA and PMA dossiers.
  3. Lead submission planning discussions and develop comprehensive strategic submission plan.
  4. Closely monitor critical path activities and provide regular updates to stakeholders.
Benefits:
  • Competitive compensation package.
  • Opportunities for professional growth and development.
  • Inclusive work environment.