Regulatory Affairs Leader, Biomaterials External Innovation

Johnson & Johnson Co.; Raynham (MA); Presencial; USD 117 000 - 201 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Long-term incentive program

Generous time-off benefits

Comprehensive leave policy

Resumo da oferta

Johnson & Johnson’s Orthopaedics team seeks a Manager, Regulatory Affairs - Biomaterials External Innovation in West Chester, PA or Raynham, MA to lead regulatory strategies for biomaterials, biologics, and externally sourced innovations. You will partner with R&D, Quality, Clinical, and Business Development to evaluate opportunities and drive submissions and lifecycle management.

You will provide expert guidance on CMC/CGMP, BLA and IDE requirements, mentor teams, deliver regulatory training,

Qualificações

• Minimum of a bachelor’s degree in a scientific, engineering, pharmacy or related field.
• 8+ years in medical device/biologics/pharma regulatory environment.
• Specialized regulatory expertise in CMC and CGMP; BLA/IDE experience preferred.
• Experience developing regulatory strategies aligned with business objectives.

Responsabilidades

• Lead regulatory activities for biomaterials, biologics, and medical devices across global submissions.
• Define and execute regulatory strategies for pipeline development and global launch readiness.
• Collaborate with R&D, Quality, Clinical, and Business Development to evaluate opportunities.
• Provide day-to-day leadership and training in regulatory requirements.

Conhecimentos

Regulatory strategy

Cross-functional leadership

CMC & CGMP

BLA & IDE familiarity

Regulatory submissions

External innovation assessment

Risk assessment

Mentoring/leadership

Formação académica

Bachelor's degree in scientific/engineering field

Advanced degree preferred

Descrição da oferta de emprego

Johnson & Johnson’s Orthopaedics team seeks a Manager, Regulatory Affairs - Biomaterials External Innovation in West Chester, PA or Raynham, MA to lead regulatory strategies for biomaterials, biologics, and externally sourced innovations. You will partner with R&D, Quality, Clinical, and Business Development to evaluate opportunities and drive submissions and lifecycle management.

You will provide expert guidance on CMC/CGMP, BLA and IDE requirements, mentor teams, deliver regulatory training,