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Sr Scientist Product Lead CMC RA
Job in
Spring House, Montgomery County, Pennsylvania, 19477, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Pharmaceutical
Pharmaceutical Science/ Research, Regulatory Compliance Specialist, Medical Science Liaison, Healthcare Compliance
Job Description & How to Apply Below
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 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 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
- Focus on innovative medicines
- Global regulatory strategy
- CMC dossier preparation
- Cross-functional collaboration across multiple countries (US, Belgium, Poland)
Multiple locations, with international scope.
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