Senior Regulatory Affairs Specialist

Pauwels Consulting; Puurs-Sint-Amands; Sur place; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Pauwels Consulting is seeking an experienced Regulatory Affairs Lead to drive regulatory activities across the Benelux region. You will manage registrations, renewals, and variations, and oversee labeling changes to ensure EU and global compliance.

The ideal candidate holds a science degree, has 8+ years in regulatory affairs, GMP experience, and strong technical writing and stakeholder influencing skills. Dutch fluency and good English are essential for success.

Qualifications

• Bachelor’s degree in a scientific or related discipline is required.
• 8+ years in regulatory affairs, conformance, or compliance in pharma.
• Strong knowledge of EU/global regulatory procedures and drug development.
• GMP environment experience and use of regulated document tools.
• Organized, analytical, with strong technical writing and stakeholder influencing.
• Fluent Dutch with good English proficiency.

Responsabilités

• Lead preparation, submission, and follow-up of registration, renewal, and variation dossiers.
• Initiate and implement label and artwork changes in compliance with regional rules.
• Provide regulatory strategy input to internal teams and support launches.
• Support complex projects like MA transfers and entity changes.
• Draft and review local/global SOPs and quality documentation.
• Manage CPP requests and regulatory databases for emerging markets.
• Coordinate with production plants to manage out-of-stock and artwork approvals.

Connaissances

Regulatory strategy

Stakeholder management

Technical writing

GMP experience

Formation

Bachelor’s degree in science or related field

Master’s or PhD (nice to have)

Outils

Regulated document management tools

Description du poste

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.

Key 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.

Qualifications

• 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.