Regulatory Affairs Lead, Biomaterials & External Innovation

Biopharma Careers; Raynham (MA); On-site; USD 120,000 - 160,000; Full time

Job summary

Johnson & Johnson is seeking a Manager, Regulatory Affairs – Biomaterials External Innovation to lead regulatory strategies for biomaterials, biologics, and combination products. This role partners with R&D, QA, Clinical, and BD teams to drive submissions, approvals, and lifecycle management across global markets.

The position emphasizes CGMP, BLA/IDE expertise, and the ability to guide early-stage external innovation opportunities while mentoring cross-functional teams and representing

Qualifications

• Minimum of a bachelor’s degree in a scientific, engineering, pharmacy, or related discipline.
• Advanced degree preferred for higher responsibility.
• Demonstrated regulatory expertise in CMC, CGMP, BLA/IDE concepts and lifecycle management.

Responsibilities

• Lead regulatory activities for biomaterials, biologics, and medical devices across global submissions.
• Develop and execute risk-based regulatory strategies to enable timely development and commercialization.
• Prepare and maintain regulatory submissions (BLAs, IDEs, PMAs, 510(k)s) and regulatory documentation.
• Mentor regulatory colleagues, provide coaching to cross-functional teams, and train partners on regulatory requirements.
• Engage with regulators and external partners to support due diligence, external innovation, and business development.

Skills

Regulatory strategy

Cross-functional leadership

Regulatory compliance

Education

Bachelor’s degree in science/engineering/pharmacy

Advanced degree preferred

Job description

Johnson & Johnson is seeking a Manager, Regulatory Affairs – Biomaterials External Innovation to lead regulatory strategies for biomaterials, biologics, and combination products. This role partners with R&D, QA, Clinical, and BD teams to drive submissions, approvals, and lifecycle management across global markets.

The position emphasizes CGMP, BLA/IDE expertise, and the ability to guide early-stage external innovation opportunities while mentoring cross-functional teams and representing