Netherlands Regulatory Affairs Specialist

Takeda Pharmaceutical; Hoofddorp; Presencial; EUR 34.000 - 97.000; Jornada completa

Descripción de la vacante

Takeda Pharmaceutical Co. is seeking a Regulatory Affairs professional in Hoofddorp, Netherlands to lead regulatory activities for marketing authorizations and lifecycle management. You will partner with Dutch health authorities and internal teams to ensure compliance across labeling, translations, and regulatory documentation.

You will act as a subject matter expert on regulatory topics, manage records, and support inspection readiness, with Dutch and English language proficiency essential.

Formación

• Experience in drug regulatory affairs within the EU region.
• Experience in a cross-functional environment.
• Excellent command of Dutch (native-level) and English languages.

Responsabilidades

• Lead regulatory activities for marketing authorizations and lifecycle management in the Netherlands.
• Act as subject matter expert for regulatory affairs to internal and external stakeholders.
• Coordinate local translations of SmPCs, labeling and patient information.
• Review labeling, packaging artworks for compliance with MA and local requirements.
• Maintain regulatory records in global and local databases and ensure timely submissions.
• Respond to health authority requests and ensure inspection readiness.
• Collaborate with Global Labelling, PSPV, and HA for risk minimization measures.

Conocimientos

Regulatory affairs expertise

Cross-functional collaboration

Attention to detail

Communication & empathy

Time management

Relationship building

Educación

BSc / advanced scientific degree

Descripción del empleo

Takeda Pharmaceutical Co. is seeking a Regulatory Affairs professional in Hoofddorp, Netherlands to lead regulatory activities for marketing authorizations and lifecycle management. You will partner with Dutch health authorities and internal teams to ensure compliance across labeling, translations, and regulatory documentation.

You will act as a subject matter expert on regulatory topics, manage records, and support inspection readiness, with Dutch and English language proficiency essential.