Accountabilities:

As an Associate Director, Regulatory Affairs, you will oversee regulatory strategy and execution for clinical and CMC submissions supporting advanced therapeutic programs. You will act as a key regulatory partner across development teams, ensuring submissions meet global requirements and supporting successful interactions with health authorities.

• Manage regulatory activities related to clinical trial applications, CMC documentation, and other regulatory filings across domestic and international markets.
• Lead planning, preparation, review, and submission of regulatory documents, including protocols, investigator brochures, CMC sections, and nonclinical documentation.
• Support regulatory strategies and pathways by communicating with health authorities and managing agency correspondence.
• Coordinate responses to regulatory questions and requests for additional information from global agencies.
• Provide regulatory guidance and interpretation of applicable regulations to clinical operations, CMC, and pharmacology/toxicology teams.
• Collaborate closely with internal stakeholders, external partners, contract research organizations, and cross-functional teams to ensure alignment and timely execution.
• Support regulatory submissions for late-stage clinical programs, including Phase 3 development activities.
• Monitor evolving regulatory guidelines and provide recommendations to ensure compliance with FDA, ICH, GMP, GCP, GLP, and other applicable standards.
• Contribute to the development and implementation of regulatory policies and best practices.
• Manage multiple projects simultaneously while maintaining strong organization, quality, and attention to detail.

Requirements:

The ideal candidate is an experienced regulatory affairs professional with strong knowledge of global drug development processes and the ability to navigate complex regulatory environments. You should have excellent communication skills, strong analytical capabilities, and experience supporting clinical-stage pharmaceutical or biotechnology programs.

• Bachelor’s degree in science or a related field required.
• 5-8 years of experience in Regulatory Affairs or a related discipline within the pharmaceutical or biotechnology industry.
• Experience supporting clinical-stage product development and regulatory submissions.
• Strong understanding of global drug development regulations, guidelines, and regulatory requirements.
• Experience with clinical trial applications for biologics, gene therapy, or pharmaceutical products is highly desirable.
• Experience with regulatory submissions or interactions involving international regions such as Japan, China, or other global markets is a plus.
• Knowledge of GCP, GMP, GLP, FDA, ICH, ISO, and related regulatory standards.
• Experience supporting complex biologics, advanced therapies, or gene therapy programs is preferred.
• Strong written and verbal communication skills with the ability to present regulatory information clearly.
• Excellent organizational skills with the ability to prioritize multiple projects in a changing environment.
• Strong analytical thinking, problem-solving abilities, and attention to detail.
• Ability to work independently while collaborating effectively within cross-functional teams.
• Proficiency with Microsoft Word, Outlook, SharePoint, Adobe Acrobat, and standard business software tools.

Benefits:

• Competitive contract compensation range of $83 - $98 per hour.
• Flexible work options including remote, hybrid, or in-person arrangements.
• 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 opportunities for professional growth and expanded responsibilities.