Principal Scientist, CMC Regulatory Affairs - Combination Products
Job in
Horsham, Montgomery County, Pennsylvania, 19044, USA
Listed on 2026-10-06
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-06
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist, Medical Science Liaison
Job Description & How to Apply Below
Role:
Principal Scientist in CMC Regulatory Affairs for drug-device combination products, supporting regulatory strategies, submissions, and lifecycle management.
- develop and execute global regulatory strategies
- review submission content for clinical and marketing applications
- provide assessments for manufacturing and product changes
- facilitate health authority interactions
- Bachelor's in a scientific, engineering, or related discipline
- minimum 8 years in Regulatory Affairs, Quality, or Product Development within regulated healthcare sectors
- experience with pharmaceutical, biotech, medical device, or combination products
- strong knowledge of global regulatory standards and cross-functional collaboration skills
- expertise in drug-device development, global regulatory submissions, and understanding of frameworks like FDA 21 CFR Part 4 and EU MDR
- RAC certification is advantageous
- focus on combination products, including biologics and pharmaceuticals
- support across pre-approval and post-market phases
- involvement in global regulatory strategy, risk assessment, and compliance
- cross-functional teamwork with R&D, manufacturing, and regulatory teams
hybrid in the US (NJ or PA); travel approximately 10% domestically or internationally.
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