Associate Director, Regulatory Affairs (Contract)

The Associate Director, Regulatory Affairs (Contract) role is based in the United States and offers support for innovative therapeutic programs in a fast-paced biotechnology environment. Key responsibilities include leading regulatory activities for CMC and clinical submissions, collaborating with cross-functional teams, and preparing high-quality regulatory filings.

Requirements

• 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.
• Strong knowledge of global drug development processes and ability to navigate complex regulatory environments.
• Excellent communication skills, strong analytical capabilities, and experience supporting clinical-stage pharmaceutical or biotechnology programs.
• 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.
• A dynamic environment offering opportunities for professional growth and expanded responsibilities.