Lead, CMC Regulatory Affairs – Drug-Device Combos

Johnson & Johnson Innovative Medicine; Spring House (PA); Hybrid; USD 150,000 - 200,000; Full time

Job summary

Scorpion Therapeutics is seeking a Principal Scientist for CMC Regulatory Affairs focused on combination products. The role involves shaping regulatory strategy across clinical, marketing, and lifecycle activities, preparing submission content, and supporting health authority interactions.

Hybrid role in the Northeast (New Jersey or Pennsylvania) with travel ~10%. Requires a strong background in FDA/EU MDR frameworks and cross-functional influence within regulated healthcare environments.

Qualifications

• Bachelor's degree in a scientific or engineering discipline required.
• 8+ years of regulatory affairs, quality, or product development experience in regulated healthcare environments.
• Experience with combination product development and global regulatory submissions preferred.

Responsibilities

• Develop regulatory strategies for clinical, marketing, and lifecycle activities.
• Prepare submission content for regulatory authorities.
• Support health authority interactions and inspections; ensure compliance with global regulations (FDA, EU MDR).

Skills

Regulatory affairs

Global submissions

Cross-functional collaboration

Education

Bachelor's in scientific or engineering discipline

Job description

Scorpion Therapeutics is seeking a Principal Scientist for CMC Regulatory Affairs focused on combination products. The role involves shaping regulatory strategy across clinical, marketing, and lifecycle activities, preparing submission content, and supporting health authority interactions.

Hybrid role in the Northeast (New Jersey or Pennsylvania) with travel ~10%. Requires a strong background in FDA/EU MDR frameworks and cross-functional influence within regulated healthcare environments.