Senior Regulatory Affairs Lead – Netherlands

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

Job summary

Takeda in Hoofddorp, Netherlands, seeks a seasoned Regulatory Affairs lead to manage Netherlands regulatory activities, and support EU regional strategies. The role partners with cross-functional teams to ensure compliant lifecycle management of products and timely submissions.

The ideal candidate has 8+ years in drug regulatory affairs, fluency in Dutch and English, and experience with Dutch authorities. This position offers full-time work with competitive compensation.

Qualifications

• At least 8 years in drug regulatory affairs.
• Experience with Dutch regulatory authorities (CBG-MEB; RIVM).
• Experience in cross-functional environments.
• Fluent in Dutch and English.

Responsibilities

• Plan and oversee regulatory activities for Netherlands (CP, MRP/DCP and national procedures).
• Manage national phases of European procedures and maintain regulatory records.
• Perform regulatory evaluation of changes for national marketing authorizations and update dossiers.
• Coordinate labeling components and translations; review packaging artwork for compliance.
• Keep internal labeling repository and external product information up to date.
• Review local promotional and non-promotional materials for regulatory compliance.
• Build relationships with local regulatory HA and communicate regulatory impact to stakeholders.
• Support EU regional RA strategists with European submissions and pre-submission meetings.
• Collaborate with PSPV on risk minimization activities and audits.

Skills

Regulatory strategy

Dutch regulatory liaison

Cross-functional collaboration

Regulatory submissions

Education

BSc., advanced scientific related degree preferred; BA accepted based on experience

Job description

Takeda in Hoofddorp, Netherlands, seeks a seasoned Regulatory Affairs lead to manage Netherlands regulatory activities, and support EU regional strategies. The role partners with cross-functional teams to ensure compliant lifecycle management of products and timely submissions.

The ideal candidate has 8+ years in drug regulatory affairs, fluency in Dutch and English, and experience with Dutch authorities. This position offers full-time work with competitive compensation.