Global Regulatory Affairs Lead
hace 3 días
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.
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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