Associate Director, Regulatory Affairs
Scorpion Therapeutics
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. Requirements: 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 Preferred: advanced degrees (PhD, PharmD, MD, MS). High-Value: global clinical trial regulatory strategy, cross-region submission planning, agency interactions, compliance with international GxP standards. Work setup: fully remote with occasional domestic/international travel (~10%). #J-18808-Ljbffr
Vacancy posted 3 days ago
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