Regulatory Dossier Lead – EU/ICH, CMC & Gap Analysis

Pauwels Consulting; Eigenbrakel; On-site; EUR 90,000 - 120,000; Full time

Job summary

Pauwels Consulting seeks an expert to lead regulatory dossier assessments and gap analyses for EU submissions, aligning with ICH and CMC requirements. You will identify risks, develop justifications, and shape remediation plans to support health authority responses.

The role demands 8+ years in pharma or life sciences, strong technical writing and stakeholder management, and fluency in English to communicate complex data clearly across cross-functional teams.

Qualifications

• 8+ years in pharmaceutical or life sciences with EU regulatory submissions, variations and remediation.
• Expert knowledge of CMC documentation, ICH guidelines, and EU regulatory requirements.
• Fluent in English.
• Proactive with excellent technical writing and stakeholder management skills.

Responsibilities

• Lead comprehensive gap analyses of regulatory dossiers and technical files against current EU and ICH requirements.
• Identify compliance risks and deficiencies to define remediation plans and strategic priorities.
• Develop scientific and regulatory justifications supporting existing data, deviations, specifications, and lifecycle changes.
• Define and recommend analytical, stability, comparability, and manufacturing studies required to close identified gaps.
• Support the preparation of Module 3 documentation and related CMC sections for regulatory dossiers.
• Provide technical expertise to cross-functional teams for dossier preparation and health authority response packages.
• Translate complex study findings into regulatory justifications and submission-ready documentation.

Skills

Regulatory submissions

Analytical writing

Process validation

Stakeholder management

Technical writing

Education

Master's or PhD in pharmaceutical sciences/chemistry/engineering

Job description

Pauwels Consulting seeks an expert to lead regulatory dossier assessments and gap analyses for EU submissions, aligning with ICH and CMC requirements. You will identify risks, develop justifications, and shape remediation plans to support health authority responses.

The role demands 8+ years in pharma or life sciences, strong technical writing and stakeholder management, and fluency in English to communicate complex data clearly across cross-functional teams.