The Group Head, Regulatory Affairs – Eastern Europe provides strategic and operational leadership to Takeda’s Regulatory Affairs organization across the Eastern European cluster of Local Operating Companies (LOCs). The Group Head leads the country Regulatory Affairs Heads, ensuring a single, consistent regulatory voice for the group, fully aligned with the European and global Regulatory Affairs strategy, and the effective execution of regulatory priorities across all cluster markets.
The role is accountable for building and guiding a high-performing, agile group Regulatory Affairs organization that accelerates patient access to Takeda’s innovative medicines and vaccines, safeguards regulatory compliance, and enables successful registration, commercialization and lifecycle management across a diverse set of national regulatory frameworks (EU Member States, and non-EU markets).
The Group Head represents group Regulatory Affairs towards internal and external stakeholders in a professional and competent manner and ensures that evolving regulatory requirements, health authority expectations and market needs are effectively incorporated into regional and enterprise strategies. The Group Head is a member of the Europe Regulatory Affairs Leadership Team.
Working in close partnership with the group and country business leadership, the Therapeutic Area Units, Marketed Products Development and key regional stakeholders, the Group Head ensures strong alignment between regional regulatory strategy and country-level execution, translating strategic priorities into consistent implementation across the LOC network while maintaining a unified regulatory voice for the group.
The Group Head ensures adherence to EU and national regulations as well as company guidelines, fosters a culture aligned with Takeda’s values (Takeda-ism), and drives decision-making according to Takeda’s Patient-Trust-Reputation-Business principle (P-T-R-B).