Associate Regulatory Affairs, Netherlands

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Job Description

About this role:

You will lead regulatory activities for assigned products in the Netherlands, providing expert guidance across marketing authorizations, lifecycle management, labelling and regulatory compliance. As a key partner to Dutch health authorities and internal stakeholders, you will help navigate regulatory requirements, manage risks and ensure our products remain compliant throughout their lifecycle.

How you will contribute:

• Performs all required activities regarding marketing authorization applications and the life cycle management of registered/authorized medicinal products in The Netherlands.
• Acts as subject matter expert for all regulatory affairs topics for internal and external stakeholders.
• Acts as point of contact for regulatory  interactions with the local health authorities in The Netherlands.
• Operates in compliance with Dutch and European legal requirements and regulations as well as company guidelines.
• Maintains accurate regulatory records/databases and ensures local product information/labelling compliance.
• Ensures regulatory inspection readiness.
• Conducts business following Takeda’s Corporate Philosophy and supports building a Culture grounded in Inclusion and our Corporate Values.
• Contributes to achieving the objectives of International Regulatory and Central Europe/LOC management and business functions.

  

Accountabilities:

 

• Plan and oversee regulatory activities for assigned products in The Netherlands (CP, MRP/DCP and national procedures); including new marketing authorizations, renewals, variations, local blue-box requirements and PSUR/PBRER activities.
• Manage the national phases of European procedures and maintain accurate regulatory records in global and local databases and archives, ensuring timely submissions, approvals and lifecycle updates.
• Perform the regulatory evaluation of changes for national marketing authorizations in accordance with global change control procedures and ensure update of the national dossiers.
• Manage product information, artworks, mock-ups and other labelling components in line with the CCDS, collaborating with the relevant functions in Global Labelling and Artwork Management to implement updates within agreed timelines. Review all packaging artworks for assigned products for consistency with the marketing authorization and local requirements (e.g. blue box, trademark and design requirements).
• Coordinate the preparation, review, approval and distribution of local translations for SmPCs, labelling and patient information. Consolidate affiliate feedback, communicate with the EU regulatory and labelling functions and keep relevant stakeholders informed.
• Keep internal labeling repository and external product information compendium timely updated.
• Review local promotional and non-promotional materials for regulatory compliance.
• Build and maintain effective relationships with the local regulatory HA including CBG-MEB, as well as Global and International Regulatory Affairs. Respond promptly and accurately to health authority requests, monitor relevant legislation, decisions and notifications and communicate their impact to stakeholders.
• Collaborate with Patient Safety & Pharmacovigilance (PSPV) regarding risk minimization activities and engage with HA to gain approval of additional risk minimization measures / educational materials.
• Support local audit and inspection readiness, identify improvement opportunities, manage day-to-day regulatory risks and recommend mitigation strategies and process enhancements.

 

 

Preferred Qualifications:

Education and Experience

• BSc., advanced scientific related degree preferred; BA accepted based on experience. 
• Experience in drug regulatory affairs / within the pharmaceutical industry in the EU region is preferable.
• Experience of working in a cross functional environment.
• Excellent command of Dutch (native-level) and English languages.

Skills and Competencies

• Analyzes issues with attention to detail and makes reasoned recommendations.
• Expresses empathy for others.
• Is able to carry out assigned activities within reasonable time.
• Adapts to changing circumstances and is able to build and maintain relationships. 

Locations

Hoofddorp, Netherlands

Base Salary Range:

€70,400.00 - €96,800.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time