Global CMC Regulatory Lead, Senior Scientist

Johnson & Johnson Innovative Medicine; Beerse; Sur place; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Sales commissions

Vacation days

Parental leave

Well-being programs

Résumé du poste

Johnson & Johnson Innovative Medicine in Beerse, Belgium seeks a Senior Scientist Product Lead CMC RA - Synthetics, New Modalities to join a global team. You will guide CMC regulatory strategy, contribute to dossier plans, and support regulatory filings across locations including Beerse, Warsaw, or East Coast USA.

This role requires strong regulatory communication skills, cross-functional collaboration, and experience with Health Authorities.

Qualifications

• BS in biological, pharmaceutical, chemical or engineering sciences with 6+ years of experience (postgraduate education included).
• Demonstrated ability to communicate regulatory requirements.
• Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry.
• Experience in drug development, analytical development, or manufacturing.
• Strong attention to detail with high-level verbal and written communication skills.
• Cross-functional and cross-company communication; defend regulatory strategy.
• Experience interacting with Health Authorities under supervision.
• Knowledge of global HA laws, regulations and guidances.

Responsabilités

• Contributes to the development of global CMC regulatory strategies and dossier plans with other CMC RA personnel.
• May participate as Regulatory CMC Lead on CMC Teams and provide regulatory input to Global Regulatory Teams.
• Supports global regulatory filings for development compounds and possibly marketed products.
• Prepares regulatory dossiers for submission to Health Authorities under supervision.
• Coordinates and manages CMC country-specific documents for global submissions.
• Assists in developing CMC Health Authority responses per proposed strategy.
• Drives continuous improvement to ensure compliance with Johnson & Johnson standards.

Connaissances

Regulatory communication

Verbal and written comms

Cross-functional collaboration

Attention to detail

Formation

BS in biological, pharmaceutical, chemical or engineering sciences

MS/PhD/PharmD preferred

Description du poste

Johnson & Johnson Innovative Medicine in Beerse, Belgium seeks a Senior Scientist Product Lead CMC RA - Synthetics, New Modalities to join a global team. You will guide CMC regulatory strategy, contribute to dossier plans, and support regulatory filings across locations including Beerse, Warsaw, or East Coast USA.

This role requires strong regulatory communication skills, cross-functional collaboration, and experience with Health Authorities.