Senior Regulatory Affairs Lead – The Netherlands

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

Job summary

Takeda Netherlands seeks a senior Regulatory Affairs professional to lead the regulatory strategy for The Netherlands and contribute to EU/International plans. You will manage marketing authorizations, renewals, variations, and lifecycle updates, and act as the primary contact with Dutch health authorities while ensuring labeling and product information compliance.

You will maintain regulatory records, ensure inspection readiness, coordinate translations for SmPCs and labeling, and translate

Qualifications

• 8+ years of experience in drug regulatory affairs.
• Experience interacting with Dutch regulatory authorities (CBG-MEB; RIVM).
• Cross-functional collaboration in a regulated environment.

Responsibilities

• Plan and oversee regulatory activities for The Netherlands (CP, MRP/DCP and national procedures).
• Manage national phases of European procedures and maintain regulatory records.
• Evaluate changes for national marketing authorizations and update dossiers.
• Coordinate labeling components with Global Labelling teams and translate SmPCs.
• Maintain labeling repository and communicate with health authorities on updates.
• Ensure regulatory inspection readiness and respond to authority requests.

Skills

Regulatory strategy

Dutch language

English language

Cross-functional teamwork

Regulatory submissions

HA interaction

Lifecycle management

Labeling compliance

Education

BSc or higher in Life Sciences

Advanced scientific degree preferred

Job description

Takeda Netherlands seeks a senior Regulatory Affairs professional to lead the regulatory strategy for The Netherlands and contribute to EU/International plans. You will manage marketing authorizations, renewals, variations, and lifecycle updates, and act as the primary contact with Dutch health authorities while ensuring labeling and product information compliance.

You will maintain regulatory records, ensure inspection readiness, coordinate translations for SmPCs and labeling, and translate