Senior Regulatory Affairs Lead – Netherlands Strategy

Takeda; Hoofddorp; On-site; EUR 103,000 - 142,000; Full time

Job summary

Takeda in Hoofddorp, Netherlands, is seeking a Regulatory Affairs professional to lead country regulatory strategy, manage marketing authorization applications, and ensure lifecycle management for the Netherlands.

You will act as subject matter expert for regulatory topics, liaise with local health authorities, ensure labeling compliance, and support EU/regional RA strategies while upholding Takeda's values.

Qualifications

• Eight years or more of regulatory affairs experience.
• Experience with Dutch regulatory authorities (CBG-MEB; RIVM).
• Experience in cross-functional team environments.
• Native Dutch and fluent English communication.

Responsibilities

• Lead regulatory strategy for assigned products in The Netherlands and contribute to EU/International strategies.
• Manage national marketing authorizations, renewals, variations, and labeling changes.
• Act as SME for regulatory topics and primary contact with Dutch health authorities.
• Ensure regulatory records, labeling, and translations are accurate and compliant.
• Support inspection readiness and collaboration with global/regional RA teams.

Skills

Dutch (native)

English (fluent)

Cross-functional collaboration

Regulatory strategy

Education

BSc or higher in a scientific field

Job description

Takeda in Hoofddorp, Netherlands, is seeking a Regulatory Affairs professional to lead country regulatory strategy, manage marketing authorization applications, and ensure lifecycle management for the Netherlands.

You will act as subject matter expert for regulatory topics, liaise with local health authorities, ensure labeling compliance, and support EU/regional RA strategies while upholding Takeda's values.