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Associate Director, Regulatory Affairs
Job in
New York, New York County, New York, 10261, USA
Listed on 2026-10-09
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-10-09
Job specializations:
-
Healthcare
Healthcare Compliance, Medical Science Liaison -
Pharmaceutical
Healthcare Compliance, Medical Science Liaison
Job Description & How to Apply Below
Role:
Associate Director, Regulatory Affairs, leading global regulatory strategies for clinical trial applications supporting the development of biopharmaceuticals for serious diseases.
Responsibilities:- oversee planning, submission, and maintenance of CTAs, INDs, and CTNs across regions including US, Canada, LATAM, and APAC
- ensure compliance with global regulations, ICH guidelines, and GCP
- coordinate with CROs, regional experts, and SMEs
- manage regulatory questions, amendments, and submission timelines to support clinical trial initiation and progress.
- Bachelor’s degree with 5+ years in pharmaceutical or biotech regulatory affairs
- experience with global clinical trial submissions and regulatory interactions
- proficiency in MS Office, Adobe, Veeva Vault
- excellent project management and cross-functional collaboration skills
- advanced degrees (PhD, PharmD, MD, MS).
- global clinical trial regulatory strategy, cross-region submission planning, agency interactions, compliance with international GxP standards.
fully remote with occasional domestic/international travel (~10%).
Position Requirements
10+ Years
work experience
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