Senior Scientist, Product Lead — CMC Regulatory (Hybrid)

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

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being programs

Insurance plans

Résumé du poste

Johnson & Johnson Innovative Medicine in Beerse, Belgium, leads cutting-edge development across regulatory sciences to enable faster, safer therapies.

As Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities, you will drive strategy, liaison with Health Authorities, and support global submissions. Hybrid role in Beerse or Warsaw with strong cross‑functional collaboration and compliance emphasis.

Qualifications

• Bachelor’s degree in Biological, Pharmaceutical, Chemical or Engineering Sciences.
• 4+ years of related pharma/healthcare experience.
• Strong knowledge of biology, chemistry or engineering in the pharmaceutical industry.
• Experience interacting with Health Authorities independently or under supervision.

Responsabilités

• Drive global CMC regulatory strategies and dossier plans with scientific rigor.
• Participate as Regulatory CMC Lead on teams to facilitate global product development.
• Prepare regulatory dossiers for Health Authorities and assist in responses.
• Coordinate country-specific CMC documents for global submissions.
• Ensure alignment of CMC strategy with global regulatory and quality objectives.

Connaissances

Regulatory Affairs

CMC Regulatory

Drug Development

Cross-functional Collaboration

Technical Writing

Formation

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

Description du poste

Johnson & Johnson Innovative Medicine in Beerse, Belgium, leads cutting-edge development across regulatory sciences to enable faster, safer therapies.

As Senior Scientist, Product Lead CMC Regulatory Affairs - Synthetics, New Modalities, you will drive strategy, liaison with Health Authorities, and support global submissions. Hybrid role in Beerse or Warsaw with strong cross‑functional collaboration and compliance emphasis.