Head Regulatory Affairs - Netherlands

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Job Description

How you will contribute:

• Leads applicable countries regulatory strategy and contributes to the regional regulatory strategies (EU / International Regulatory) and defines the local implementation in support of enabling patient access.
• 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 primary 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.
• Support EU regional RA strategists in their HA communication related to European submissions for development/marketed products, in particular where The Netherlands are reference member state or (co)rapporteur. Facilitate preparation for pre-submission or scientific advice meetings with the local HA.
• 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. 
• A minimum of 8 years of experience in drug regulatory affairs.
• Experience in interaction with Dutch regulatory authorities (CBG-MEB; RIVM).
• Experience of working in a cross functional environment.
• Excellent command of Dutch (native-level) and English languages.

Skills and Competencies

• Can speak up and is perceived as a natural, assertive authority whom peers trust for their advice; communicates externally/with authorities in concise and respectful language.
• Develops concise strategic plans, understandably outlines the opportunities and risks of alternative scenarios before proposing a decision; proposes risk mitigation plans and identifies area for improvement
• Acts as an ally to support individuals as a whole and promotes an inclusive culture; practices active listening, encourages open dialogue, feedback, and diverse opinions.
• Is able to prioritise activities and execute within reasonable time with limited supervision; can take some tactical decisions.
• Adapts to changing circumstances and is able to build and maintain relationships.
• Has their voice heard as remote participant to regional, local or cross functional teams; influences meeting agendas & outcomes to optimally integrate regional or local strategic needs. 
• Receives and gives feedback; expresses ideas, questions, and disagreement.
• Is self-aware and able to function effectively while meeting the multiple challenges of daily life with a sense of energy, vitality, and confidence.

 

 

Locations

Hoofddorp, Netherlands

Base Salary Range:

€103,000.00 - €141,680.00

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