CMC Regulatory Lead Scientist: Synthetics & New Modalities

Johnson Johnson; Beerse; Hybride; EUR 90 000 - 130 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities. This position is a hybrid role and can be located in Beerse, Belgium or Warsaw, Poland.

The Senior Scientist will drive scientific strategy, contribute to CMC regulatory plans, prepare regulatory dossiers, and work with Global CMC Regulatory Affairs to enable development of medicines across regions.

Responsabilités

• Drive scientific strategy and critical decision-making through integration of disease biology, pharmacology, biomarkers, human genetics, and clinical data.
• Contribute to the development of global CMC regulatory strategies and dossier plans according to scientific/risk-based principles in collaboration with other Global CMC Regulatory Affairs (CMC RA) personnel.
• May participate as the Regulatory CMC Lead on CMC Teams and represent CMC RA by providing regulatory expertise on the CMC Core Team and Global Regulatory Team (GRT) to facilitate successful product development globally and to provide input on team recommendations.
• Support global regulatory filings for mainly development compounds, and potentially also marketed products, in collaboration with other CMC RA senior personnel.
• Prepare regulatory dossiers for submission to Health Authorities under supervision.
• Coordinates, compiles, and manages CMC country specific documents required as part of the approval process for global submissions.
• Assist in developing and preparing CMC Health Authority responses as needed according to the proposed strategy.
• May participate in selected initiatives within CMC RA/GRA.
• Drive a culture of continuous improvement to ensure compliance with Johnson & Johnson standards, regulatory requirements and expectations. Communicate critical issues to Management.

Connaissances

Regulatory Affairs

CMC Regulatory

Cross-functional collaboration

Strategic planning

Description du poste

Johnson & Johnson Innovative Medicine R&D is recruiting for a Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities. This position is a hybrid role and can be located in Beerse, Belgium or Warsaw, Poland.

The Senior Scientist will drive scientific strategy, contribute to CMC regulatory plans, prepare regulatory dossiers, and work with Global CMC Regulatory Affairs to enable development of medicines across regions.