Senior Scientist, CMC Regulatory Affairs (Global)

Johnson & Johnson Innovative Medicine; Gierle; Hybride; EUR 73 000 - 115 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine 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.

Join a team driving global CMC regulatory strategies, preparing dossiers for Health Authorities, and coordinating regulatory filings across multiple countries to ensure compliant, timely submissions and lifecycle management.

Qualifications

• Bachelor's degree in a relevant scientific discipline; advanced degree preferred.
• Minimum 4 years in pharmaceutical or health care industry.
• Experience with global Health Authority regulations and submissions.

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.
• May contribute to the development/implementation of global CMC regulatory strategies and dossier plans for development compounds (and marketed products).
• Ensure the CMC regulatory strategy is in alignment with the strategies of global Regulatory Affairs, the therapeutic area, commercial, regional functions and the Quality Target Product Profile (QTPP).
• Assure connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader) or other senior level CMC RA personnel.
• Provide input to and assists in the preparation of dossiers for submission to Health Authorities (NDA/BLA /MAA/IND/CTA and post approval variations).
• Assist in providing accurate regulatory assessments of CMC changes to teams for execution of regulatory planning and implementation.
• Escalate issues to CMC RA Management that affect registration, regulatory compliance and continued lifecycle management of the product.
• Assist in execution or development of contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product.
• Provide CMC Regulatory support to health authority inspections.

Connaissances

Regulatory Affairs

CMC

Drug Development

Regulatory Strategy

Formation

Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences

Description du poste

Johnson & Johnson Innovative Medicine 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.

Join a team driving global CMC regulatory strategies, preparing dossiers for Health Authorities, and coordinating regulatory filings across multiple countries to ensure compliant, timely submissions and lifecycle management.