Associate Director Regulatory Affairs – Cell Therapy

Hybrid Position: Philadelphia (or) Boston

My client is a late-stage global biotechnology company developing first-in-class T-cell-based cancer immunotherapies. They are seeking an Associate Director of Regulatory Affairs to lead, develop, and execute global regulatory strategies for assigned programs.

Position: Reporting directly to the Vice President of Regulatory Affairs, you will serve as the primary liaison to regulatory agencies and lead submission activities. The Associate Director of Regulatory Affairs will be responsible for developing, implementing, and leading global regulatory strategies designed to facilitate the success of our products across their entire lifecycle.

Responsibilities:

• Leads and defines the global regulatory strategy and executes regulatory strategies.
• Preparation and supervision of preparation of regulatory submissions, including INDs, CTAs, GMOs, IDEs, amendments, annual reports, meeting briefing documents, responses to regulatory agency information requests, marketing authorization applications, and other regulatory submissions, as applicable.
• Serves as the primary liaison with FDA and other regulatory agencies throughout the development of projects, including support for regulatory agency meetings and teleconferences.
• Identify and assess existing and new regulations, guidance documents, international standards, or consensus standards; provide interpretive guidance and ensure applicable implementation into development planning and execution.
• Ensures that all regulatory activities and documents submitted to regulatory agencies are evaluated to ensure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance to facilitate agency review and acceptance.
• Represents Global Regulatory Affairs as the primary contact on regulatory aspects of the projects and as a member of the cross-functional project team, providing regulatory guidance/strategy/perspective in team meetings and presentations at senior leadership governance meetings.
• Participate in due diligence activities on potential licensing, acquisition, or collaboration opportunities.
• Reviews and establishes standard operating procedures (SOPs) and global regulatory affairs processes.
• Manages vendors and clinical research organizations (CROs) performing regulatory activities on behalf of the company.
• Ensure regulatory documentation is maintained appropriately.

Qualifications & Experience:

• Bachelor’s Degree required. Advanced Degree preferred.
• At least 6 years of Global Regulatory Affairs experience.
• Must have Cell or Gene Therapy experience.
• Must have experience filing regulatory dossiers (CTAs, INDs, IMPDs, IDEs)
• Oncology experience is strongly preferred.
• Experience with BLAs/NDAs/MAAs preferred.
• Solid working knowledge of relevant domestic and global regulations and guidance.

#lifesciences #newjobalert #regulatoryaffairs #celltherapy #oncology #biotech #executivesearch #regulatorystrategy #drugdevelopment #regulatoryaffairsrecruiter