Senior Scientist, CMC Regulatory Strategy Lead

Johnson & Johnson Innovation; Antwerpen; Hybride; EUR 73 000 - 115 000; Plein temps

Avantages offerts par ce poste

Hybrid work

Résumé du poste

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

You will drive regulatory strategy for global CMC submissions, participate as lead on CMC Teams, and collaborate across Global Regulatory Affairs to enable development and lifecycle management of development compounds and some marketed products.

Qualifications

• Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences required; advanced degree preferred.
• Minimum 4 years of related pharmaceutical or health care industry experience.
• Knowledge of biology, chemistry, or engineering relevant to the pharmaceutical industry.
• Experience with Health Authorities interactions.
• Strong written and verbal communication skills; attention to detail.

Responsabilités

• Drive scientific strategy by integrating disease biology, pharmacology, biomarkers and clinical data.
• Support global CMC regulatory strategies and dossier plans.
• May serve as CMC Regulatory Lead on teams and provide regulatory input to leaders.
• Prepare regulatory dossiers for Health Authority submissions under supervision.
• Coordinate CMC documents for global submissions and lifecycle management.
• Contribute to continuous improvement and regulatory compliance.

Connaissances

Analytical Reasoning

Coaching

Communication

Regulatory knowledge

Cross-functional collaboration

Formation

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

Advanced degree preferred (M.S./PharmD/Ph.D.)

Description du poste

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

You will drive regulatory strategy for global CMC submissions, participate as lead on CMC Teams, and collaborate across Global Regulatory Affairs to enable development and lifecycle management of development compounds and some marketed products.