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Associate Principal Scientist Regulatory CMC - Biologics; R4-Synthetic Moieties; Drug-Linker) OF ADCs AND Bioconjugates
Job in
Rahway, Union County, New Jersey, 07065, USA
Listed on 2026-10-06
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-06
Job specializations:
-
Pharmaceutical
Regulatory Compliance Specialist
Job Description & How to Apply Below
Associate Principal Scientist/Associate Director in Regulatory CMC focusing on biologics conjugates, primarily ADCs and bio-conjugates, with responsibilities spanning global regulatory strategy development, dossier preparation, and lifecycle management for synthetic moieties like drug-linkers. The position involves providing regulatory leadership within cross‑functional teams, ensuring compliance with international regulations, and managing submission activities for INDs, BLAs, MAAs, and post‑approval changes.
Key Responsibilities- Integrating regulatory strategies across product components
- Assessing global requirements
- Collaborating on scientific and regulatory documentation
- B.S. in Chemistry, Chemical Engineering, Biochemistry, or related field
- 10+ years' relevant experience including process chemistry, analytical development, manufacturing, or CMC development
- Demonstrated regulatory expertise in small molecules or chemically synthesized modalities
- Experience with drug-linkers
- ADCs
- Peptides
- Oligonucleotides
- External partner collaboration
- Global lifecycle management
- Biologics conjugates
- ADCs
- Drug-linkers
- Regulatory submissions (IND/BLA/MAA)
- Global CMC strategies
- Post-approval lifecycle
- GxP compliance
Hybrid; no travel required.
Position Requirements
10+ Years
work experience
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