Global Regulatory Affairs Lead

Global Regulatory Affairs Lead

Sobi

Remote, Switzerland

Key Responsibilities and Accountabilities

Including, but not limited to the following:

• Single point of contact/single point of accountability within GRA on the Core Asset Team (CAT) and Medicines Development Team (MDT) for assigned program(s)
• Chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s)
• Provides global regulatory leadership of assigned program(s)
• Develops global regulatory strategies, including risk assessment and mitigation strategies. Champions use of expedited regulatory pathways globally to accelerate patients’ access
• Attends major/critical regulatory Agency meetings (US FDA, EMA/CHMP, PMDA, NMPA/CDE) for assigned program(s)
• May present to Senior Leadership regarding assigned program(s)
• Cooperates with other departments and affiliates within Sobi, regulatory authorities, partners and regulatory consultants
• Participates in strategic and regulatory evaluations of in-licensing matters
• May have direct oversight/management of Regulatory Affairs team members supporting assigned program(s)
• Authority to approve services and costs within budget and delegation from Sobi authorized signatories
• Review regulatory SOPs as needed
• Participate in operational excellence work (improvement projects) as needed.

Qualifications

• Degree in Life Sciences
• Expert on all Regulatory Affairs processes, applications and regulatory environment to achieve and maintain marketing authorizations
• Good knowledge of drug development and the rare diseases regulatory environment
• Experience in haematology is preferred
• Very good knowledge in written and oral English, knowledge of other languages is an upside but not required

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