Director Regulatory Scientific Affairs (m/w/d)

Responsible for the medical scientific content of regulatory dossiers for submissions worldwide, e.g. of marketing authorisation applications (MAA), variations, renewals of MA:

• Organisation and review of Non-clinical & Clinical Overviews (Modules 2.4 & 2.5), if applicable in cooperation with external service providers
• Medical scientific input and support of Regulatory Affairs BU Generics and Complex Formulations during regulatory procedures, e.g. MAAs, variations and renewals of MAs
• Compilation of "Addendum to the Clinical Overview" or "Clinical Expert Statement" for renewals of MAs in cooperation with Pharmacovigilance
• Medical risk assessment in support of the BU Generics and Complex Formulation’s portfolio team including assessment of changes of the product information and provision of suitable text modules
• Medical scientific risk assessment for marketed products of the BU Generics and Complex Formulations
• Medical assessment during due-diligence for in-licensing projects

Representative of the BU Generics and Complex Formulations in the Fresenius Kabi medical scientific community including internal decision-making bodies with respect to product information updates

• Academic scientific degree in human medicines
• Several years of professional experience in Medical Scientific within a Pharmaceutical Company or CRO
• Basic knowledge and understanding of the regulatory environment in the field of generic products
• Ability to communicate clearly and effectively, analytical skills, pays attention to detail
• Capability to manage multiple priorities in an efficient manner; well organized, able to work in an international team environment
• Business-fluent in English

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