Regulatory Affairs Lead - Biomaterials External Innovation

Johnson & Johnson Innovative Medicine; Raynham (MA); Vor Ort; USD 117.000 - 201.000; Vollzeit

Zusammenfassung

Johnson & Johnson Innovative Medicine seeks a Manager, Regulatory Affairs – Biomaterials External Innovation for West Chester, PA or Raynham, MA. Lead regulatory strategies for biomaterials, biologics, and combination products and partner with cross-functional teams.

This role emphasizes CMC/CGMP expertise, early-stage due diligence, and global submissions to accelerate development and launch readiness in key markets. Strong leadership and external partnerships are essential.

Qualifikationen

• Bachelor’s degree in a scientific or technical discipline; advanced degree preferred.
• Minimum 8 years of regulated industry experience (devices, biologics, or pharma).
• Specialized regulatory expertise in CMC and CGMP; BLA/IDE experience preferred.
• Experience guiding early-stage external innovation and due diligence.

Aufgaben

• Lead regulatory activities for biomaterials, biologics, and medical devices.
• Develop and execute risk-based regulatory strategies for portfolio.
• Prepare and maintain regulatory submissions and technical documents.
• Collaborate with R&D, Quality, Clinical, and BD teams.
• Provide leadership and coaching to Regulatory Affairs teams.
• Deliver regulatory training for cross-functional partners.

Kenntnisse

CMC CGMP expertise

BLA/IDE experience

Regulatory strategy development

Cross-functional leadership

Regulatory submissions

External due diligence

Ausbildung

Bachelor’s degree in science/engineering/pharmacy

Advanced degree preferred

Jobbeschreibung

Johnson & Johnson Innovative Medicine seeks a Manager, Regulatory Affairs – Biomaterials External Innovation for West Chester, PA or Raynham, MA. Lead regulatory strategies for biomaterials, biologics, and combination products and partner with cross-functional teams.

This role emphasizes CMC/CGMP expertise, early-stage due diligence, and global submissions to accelerate development and launch readiness in key markets. Strong leadership and external partnerships are essential.