Job Description
Key Responsibilities and Accountabilities:
Including, but not 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.
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
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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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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