Associate Director, Regulatory Affairs (Contract)

📋 Description

• Oversee regulatory strategy and execution for clinical and CMC submissions for advanced therapeutic
• Regulatory partner across development teams to ensure submissions meet global requirements and
• Manage regulatory activities related to clinical trial applications, CMC documentation, and other
• Lead planning, preparation, review, and submission of regulatory documents (protocols, investigator
• Coordinate agency responses and information requests from global agencies.
• Provide regulatory guidance to clinical operations, CMC, and pharmacology/toxicology teams.

🎯 Requirements

• Bachelor’s degree in science or related field.
• 5-8 years in Regulatory Affairs or related discipline within pharma/biotech.
• Experience supporting clinical-stage product development and regulatory submissions.
• Strong understanding of global drug development regulations, guidelines, and requirements.
• Experience with regulatory submissions/interactions involving international markets (Japan, China
• Knowledge of GCP, GMP, GLP, FDA, ICH, ISO regulatory standards.

🎁 Benefits

• Competitive contract compensation range of $83 - $98 per hour.
• Flexible work options including remote, hybrid, or in-person.
• Opportunity to contribute to innovative therapeutic programs with meaningful patient impact.
• Exposure to global regulatory strategy and advanced biotechnology development.
• Collaboration with experienced scientific, clinical, and regulatory professionals.
• Dynamic environment offering professional growth and expanded responsibilities.