Associate Director, Regulatory Affairs

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%).