RWE & Phase IV Strategy Lead

Realogy Holdings; Atlanta (GA); Sur place; USD 140 000 - 180 000; Plein temps

Résumé du poste

Realogy Holdings is seeking a Regulatory Affairs leader to provide technical oversight and leadership on Phase IV research support for CORE within Medical Affairs, guiding strategic RWE plans and study protocols. You will manage regulatory submissions, ensure compliance, and coordinate with external partners, academic institutions and government entities to advance influenza vaccine Phase IV programs.

The role also involves mentoring research staff and contributing to publications and

Responsabilités

• Assure regulatory compliance with internal procedures and external standards.
• Submit documents to regulatory agencies; assists with communication, negotiations and follow-up deliverables.
• Establish and maintain policies, guidelines, and procedures for the regulatory affairs department.
• Provide regulatory support on product development and project teams.
• Provide regulatory assessments for manufacturing design changes and validation activities.
• Review and approve test protocols to support regulatory submissions.
• Ensure product launches and distribution complies with applicable regulations.
• Provide regulatory input in quality management system, assessments, product development and compliance.

Description du poste

Realogy Holdings is seeking a Regulatory Affairs leader to provide technical oversight and leadership on Phase IV research support for CORE within Medical Affairs, guiding strategic RWE plans and study protocols. You will manage regulatory submissions, ensure compliance, and coordinate with external partners, academic institutions and government entities to advance influenza vaccine Phase IV programs.

The role also involves mentoring research staff and contributing to publications and