Senior Scientist, CMC Regulatory Affairs - Combo Products

Johnson & Johnson Innovative Medicine; Beerse; Hybride; EUR 80 000 - 138 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Well-being reimbursement

Résumé du poste

Johnson & Johnson Innovative Medicine is seeking a Principal Scientist, CMC Regulatory Affairs - Combination Products for a hybrid role located in Beerse, Belgium or Warsaw, Poland.

The role provides regulatory subject matter expertise for drug-device combination products and supports global submissions, lifecycle management, and Health Authority interactions in a dynamic, matrixed environment.

Qualifications

• Bachelor's degree in a scientific, engineering, pharmaceutical, regulatory science, or related discipline is required.
• Advanced degree (Masters, PharmD, Ph.D) preferred.

Responsabilités

• Provide regulatory expertise for global combination product and medical device requirements.
• Develop and execute regulatory strategies for submissions and lifecycle management.
• Review device and combination product submission content and design control deliverables.
• Provide regulatory assessments for manufacturing and product changes.
• Support Health Authority interactions and briefing books.

Connaissances

Regulatory Affairs

Quality Systems

Product Development

Regulatory Strategy

Cross-functional Collaboration

Regulatory Writing

Communication

Analytical Thinking

Formation

Bachelor's degree

Advanced degree

Description du poste

Johnson & Johnson Innovative Medicine is seeking a Principal Scientist, CMC Regulatory Affairs - Combination Products for a hybrid role located in Beerse, Belgium or Warsaw, Poland.

The role provides regulatory subject matter expertise for drug-device combination products and supports global submissions, lifecycle management, and Health Authority interactions in a dynamic, matrixed environment.