Senior Regulatory Affairs Lead, Benelux (Pharma)

Pauwels Consulting; Puurs-Sint-Amands; On-site; EUR 90,000 - 130,000; Full time

Job summary

Pauwels Consulting is seeking an experienced Regulatory Lead to head regulatory activities for the Benelux region. You will manage registration dossiers, renewals, variations, and artwork changes, ensuring compliance with EU and global regulations.

You will provide strategic regulatory guidance to internal teams, support launches, and drive regulatory transfers and entity changes. You will draft SOPs, manage regulatory databases, and coordinate with production plants to ensure timely artwork

Qualifications

• Bachelor’s degree in a scientific discipline.
• 8+ years in regulatory affairs in pharma.
• Deep knowledge of EU/global regulatory procedures.
• GMP experience and regulated document management.

Responsibilities

• Manage registration dossiers, renewals, and variations.
• Lead label and artwork changes to comply with regional regulations.
• Provide regulatory strategy to stakeholders and participate in launches.
• Support MA transfers and entity changes across the region.
• Draft and review local/global SOPs and QA docs.
• Oversee CPP requests and regulatory databases.
• Coordinate with production plants for stock alerts and artwork approvals.

Skills

Regulatory leadership

EU regulatory knowledge

Technical writing

Stakeholder influencing

Education

Bachelor's degree in science or related field

Tools

Regulatory systems

Job description

Our client, a prominent pharmaceutical organization, is seeking an experienced professional to lead regulatory activities within the Benelux region. The role focuses on ensuring the quality and compliance of regulatory data and processes while managing marketing authorizations for medicinal products.

Responsibilities

• Manage the preparation, submission, and follow-up of registration dossiers, renewals, and variation dossiers for medicinal products.
• Lead the initiation, review, and implementation of label and artwork changes to ensure full compliance with regional regulations.
• Provide strategic regulatory expertise to internal stakeholders and participate in launch planning and business unit meetings.
• Support complex projects including marketing authorization transfers and legal entity changes across the regional market.
• Draft and review local and global SOPs, work instructions, and other quality-related documentation.
• Oversee the handling of CPP and ancillary document requests for emerging markets and maintain internal regulatory databases.
• Coordinate with production plants and hubs to manage out-of-stock notifications and artwork approvals.
  
  

Requirements

• You have a Bachelor’s degree in a scientific or related discipline.
• You bring 8+ years of experience in regulatory affairs, conformance, or compliance within the pharmaceutical industry.
• You possess advanced knowledge of EU and global regulatory procedures, marketing authorizations, and drug development practices.
• You have experience working in a GMP environment and utilizing regulated document management tools.
• You’re an organized and analytical professional with strong skills in technical writing and stakeholder influencing.
• You have a perfect command of Dutch with good knowledge of English.
  
  

Nice to Haves

• Master's, MBA, or PhD in a scientific field.
• Experience with advanced digital regulatory systems and innovative compliance solutions.