Senior Scientist, Product Lead CMC Regulatory Affairs

Scorpion Therapeutics; Horsham (PA); Hybrid; USD 130,000 - 170,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities to guide regulatory strategies across development. You will integrate disease biology, pharmacology, and clinical data to shape scientific strategy and global CMC approaches.

You will lead cross‑functional regulatory activities, prepare submissions, and ensure compliance with health authority standards while supporting lifecycle management and inspections.

Qualifications

• Bachelor's degree in biological, pharmaceutical, chemical, or engineering sciences.
• 4+ years' industry experience, including drug development, analytical development, or manufacturing.
• Familiarity with global health authority regulations.
• Strong communication and regulatory strategy skills.

Responsibilities

• Integrating disease biology, pharmacology, and clinical data into scientific strategy.
• Developing global CMC regulatory approaches and dossiers.
• Leading CMC regulatory activities in cross-functional teams.
• Preparing and managing regulatory submissions, responses, and documentation for health authorities.
• Ensuring compliance with regulatory standards.
• Supporting development compounds and marketed products, lifecycle management, and inspections.

Skills

Regulatory strategy

Communication

Cross-functional collaboration

Education

Bachelor's degree in biological, pharmaceutical, chemical, or engineering sciences

Master's/PharmD/Ph.D. preferred

Job description

Role: Senior Scientist, Product Lead CMC Regulatory Affairs for Synthetics and New Modalities

supporting development and regulatory strategies for innovative medicines.

Responsibilities

• integrating disease biology, pharmacology, and clinical data into scientific strategy
• developing global CMC regulatory approaches and dossiers
• leading CMC regulatory activities in cross-functional teams
• preparing and managing regulatory submissions, responses, and documentation for health authorities
• ensuring compliance with regulatory standards
• supporting both development compounds and marketed products, providing regulatory input for lifecycle management, and supporting inspections

Qualifications

• Bachelor's degree in biological, pharmaceutical, chemical, or engineering sciences
• 4+ years' industry experience, including drug development, analytical development, or manufacturing
• familiarity with global health authority regulations
• strong communication and regulatory strategy skills

Preferred

• advanced degrees (Master's, PharmD, Ph.D.)

High-Value

• focus on CMC regulatory strategies for biologics, small molecules, or novel modalities, supporting multi-stage development (IND, CTA, NDA/BLA), across global markets

The position offers hybrid work in NJ or PA with potential for international collaboration.