Sr Scientist Product Lead CMC RA

Scorpion Therapeutics; Spring House (PA); On-site; USD 140,000 - 190,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Scientist Product Lead CMC RA to drive global CMC regulatory strategies for innovative medicines. You will lead regulatory dossier preparation and coordinate health authority interactions.

Collaborating with cross-functional teams in the US and Europe, you will shape global regulatory plans across development stages and filings. A BS with 6+ years and advanced degrees are preferred to navigate complex regulatory environments.

Qualifications

• BS in biological, pharmaceutical, chemical, or engineering sciences with 6+ years of industry experience.
• Advanced degrees (MS, Ph.D., Pharm.D.) preferred.
• Knowledge of biology, chemistry, engineering relevant to pharma, drug development or manufacturing, and global health authority regulations.

Responsibilities

• Develop and implement regulatory dossiers and strategies for development compounds.
• Support global filings.
• Prepare and coordinate regulatory submissions and responses to health authorities.
• Contribute to CMC team initiatives.

Skills

Strong communication

Attention to detail

Regulatory navigation

Education

Bachelor's degree in biological/pharmaceutical/chemical/engineering sciences

MS/PhD/PharmD preferred

Job description

Role

Senior Scientist Product Lead CMC RA - Synthetics, New Modalities, focusing on global CMC regulatory strategies for innovative medicines.

Responsibilities

• Develop and implement regulatory dossiers and strategies for development compounds
• Support global filings
• Prepare and coordinate regulatory submissions and responses to health authorities
• Contribute to CMC team initiatives

Collaborates

Collaborates with cross-functional teams including Therapeutic Area Regulatory Affairs and Quality; may serve as Regulatory CMC Lead on CMC teams and represent CMC RA in global regulatory discussions.

Requirements

• BS in biological, pharmaceutical, chemical, or engineering sciences with 6+ years of industry experience
• Advanced degrees (MS, Ph.D., Pharm.D.) preferred

Knowledge

Knowledge of biology, chemistry, engineering relevant to pharma, drug development or manufacturing, and global health authority regulations is essential.

Skills

• Strong communication
• Attention to detail
• Ability to navigate complex regulatory environments

High-Value

• Focus on innovative medicines
• Global regulatory strategy
• CMC dossier preparation
• Cross-functional collaboration across multiple countries (US, Belgium, Poland)

Work setup

Multiple locations, with international scope.