Biotech Regulatory & Quality Implementation Leader

Nūmi; Paris; Sur place; EUR 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Partial health insurance coverage

Transportation coverage

Lunch coverage

Employee growth opportunities

Résumé du poste

Nūmi, a Paris-based biotech company, seeks a Senior Quality & Regulatory leader to own regulatory strategies and build our quality systems. You will translate counsel guidance into effective internal processes and drive dossier filings globally by 2026.

You will champion speed, consistency, and innovation in regulatory affairs, working with R&D, bioprocess and downstream teams to ensure compliant, scalable operations.

Qualifications

• BSc/MSc in biology, chemistry, food science or related field.
• 5+ years in quality control or regulatory affairs in biotech or food industry.
• Knowledge of GMP/GLP and ISO frameworks as relevant.

Responsabilités

• Interpret regulatory recommendations and implement into internal practices.
• Develop regulatory roadmap for dossiers across EU, US, and other regions.
• Lead development and improvement of QMS for bioproduction.
• Establish SOPs, change control, and CAPA processes.
• Prepare for inspections and agency audits.
• Collaborate with R&D and process teams to integrate quality considerations.
• Drive regulatory content standards and knowledge repositories.

Connaissances

Quality management

Regulatory affairs

Project management

Cross-functional collaboration

Formation

BSc/MSc in biology/chemistry/food science or related

Description du poste

Nūmi, a Paris-based biotech company, seeks a Senior Quality & Regulatory leader to own regulatory strategies and build our quality systems. You will translate counsel guidance into effective internal processes and drive dossier filings globally by 2026.

You will champion speed, consistency, and innovation in regulatory affairs, working with R&D, bioprocess and downstream teams to ensure compliant, scalable operations.