Global Regulatory Affairs Lead

hace 3 días


Madrid, Madrid, España Sobi Group A tiempo completo
Job Description

Sobi Group is committed to developing and delivering innovative therapies to improve the lives of people with rare diseases. We are seeking a highly skilled Global Regulatory Affairs Lead to join our team.

Key Responsibilities:
  • Provide global regulatory leadership for assigned programs, developing strategies for risk assessment and mitigation.
  • Chair a Global Regulatory Team (GRT) of regulatory Subject Matter Experts and provide single point of contact for assigned programs.
  • Champion the use of expedited regulatory pathways globally to accelerate patients' access.
  • Attend major/critical regulatory Agency meetings and present to Senior Leadership as needed.
  • Cooperate with other departments and affiliates within Sobi, regulatory authorities, partners, and regulatory consultants.
  • Participate in strategic and regulatory evaluations of in-licensing matters and have direct oversight/management of Regulatory Affairs team members.
Main Contacts:

Internal core interactions: All functions within Sobi, but in particular Commercial, Pharmacovigilance & Patient Safety, Supply Chain, Quality, Manufacturing & Supply, Clinical Development, Global Medical & Scientific Affairs, Project & Portfolio Management as well as Management Teams, Governance Teams, and affiliates.

External core interactions with: Regulatory Authorities, CROs, Consultants, Partners.

May act as point of contact with US FDA or EMA.



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