Principal Scientist, CMC Regulatory Affairs — Drug‑Device

Biopharma Careers; Beerse; Hybride; EUR 80 000 - 138 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson Innovative Medicine R&D is recruiting for a Principal Scientist, CMC Regulatory Affairs - Combination Products. This hybrid role can be located in Beerse, Belgium or Warsaw, Poland.

The Principal Scientist will provide CMC regulatory subject matter expertise for drug-device combination products and related device constituents, supporting pre- and post-approval programs across global markets.

Qualifications

• Bachelor’s degree or equivalent in a scientific, engineering, pharmaceutical, regulatory science, or related discipline.
• Advanced degree (Masters, PharmD, Ph.D) preferred.
• 8+ years of experience in Regulatory Affairs, Quality, and/or Product Development.
• Experience in pharmaceutical, biotechnology, medical device, or combination products.
• Strong written and verbal communication skills.
• Ability to travel up to 10%.

Responsabilités

• Provide regulatory expertise and interpretation of global requirements for drug-device combination products.
• Develop and execute regulatory strategies for clinical, marketing, and lifecycle submissions.
• Review device- and combination product-specific submission content for trials and Notified Body dossiers.
• Provide regulatory assessments for manufacturing, device, and product changes globally.
• Develop strategies for Health Authority interactions and briefing books.
• Participate in cross-functional initiatives to improve regulatory processes.
• Monitor emerging global device and combination product regulations and communicate impacts.
• Support lifecycle management, regulatory compliance, and related activities.

Connaissances

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Health Authority interactions

Technical writing

Problem solving

Formation

Bachelor's degree

Advanced degree

Description du poste

Johnson & Johnson Innovative Medicine R&D is recruiting for a Principal Scientist, CMC Regulatory Affairs - Combination Products. This hybrid role can be located in Beerse, Belgium or Warsaw, Poland.

The Principal Scientist will provide CMC regulatory subject matter expertise for drug-device combination products and related device constituents, supporting pre- and post-approval programs across global markets.