Regulatory Project Manager - Temp

Regeneron Pharmaceuticals, Inc.; New Jersey; Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Temporary Associate Manager to join Regulatory Project Management. The role leads strategic planning and execution of regulatory milestones from IPA to post-marketing, with potential as the lead for a therapeutic area.

On-site work at multiple locations is required. The position requires 5+ years of industry experience and strong regulatory knowledge of FDA, EMA, ICH guidelines.

Formación

• 5+ years of industry and/or relevant experience.
• Strong knowledge of FDA, EMA, ICH regulations and guidelines.
• Working knowledge of MS Office applications and Adobe Acrobat; SharePoint desirable.

Responsabilidades

• Lead strategic planning and execution of regulatory milestones from IPA to post-marketing.
• May serve as Reg PM lead for assigned therapeutic area and ensure success of regulatory programs.
• Coordinate regulatory timelines, submission plans, and cross-functional milestones.
• Chair or facilitate regulatory sub-team meetings and kickoff meetings for major submissions.
• Communicate program projections and progress to cross-functional teams and upper management.

Conocimientos

Regulatory project management

Cross-functional leadership

Regulatory submissions

MS Office

Adobe Acrobat

SharePoint

Herramientas

MS Office

Adobe Acrobat

SharePoint

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a Temporary Associate Manager to join Regulatory Project Management. The role leads strategic planning and execution of regulatory milestones from IPA to post-marketing, with potential as the lead for a therapeutic area.

On-site work at multiple locations is required. The position requires 5+ years of industry experience and strong regulatory knowledge of FDA, EMA, ICH guidelines.