Research Associate Scientific Senior

Pauwels Consulting; Eigenbrakel; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Regulatory submissions

Analytical writing

Process validation

Stakeholder management

Technical writing

Formation

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

Description du poste

Our client, a leading life sciences organization, is seeking an expert to lead comprehensive regulatory dossier assessments and file gap analyses. The project focuses on identifying compliance risks and developing scientific justifications to support regulatory submissions and health authority responses.

• 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.

• Master's degree or PhD in Pharmaceutical Sciences, Chemistry, Engineering, or a related scientific discipline.
• You have 8+ years of experience in the pharmaceutical or life sciences industry with a focus on EU regulatory submissions, variations, and remediation activities.
• You bring expert knowledge of CMC documentation, ICH guidelines, and EU regulatory requirements.
• You possess strong expertise in analytical development, validation, and manufacturing process validation.
• You have extensive experience reviewing CMC, analytical, and manufacturing documentation within GMP, GxP, or QSR environments.
• You are proactive with excellent technical writing and stakeholder management skills.
• You are fluent in English.

Nice to Have

• Experience leading cross-functional compliance projects.
• Knowledge of basic technical theories and research design concepts within a lab environment.