Associate Director, Global Regulatory Affairs Region

2012 CSL Behring L.L.C. - King of Prussia, PA

Part-time - Senior

Hybrid - King of Prussia, PA

10,001+ employees

About the position

The Associate Director, Global Regulatory Affairs at CSL Behring plays a crucial role in supporting the regulatory strategy for the company's biotherapeutics portfolio. This position involves collaboration with regional health authorities, contributing to regulatory assessments, and ensuring alignment between regional and global regulatory strategies throughout the product lifecycle. The role is hybrid and based in King of Prussia, PA, reporting to the Director of Global Regulatory Affairs.

Responsibilities

• Support the GRA Region regulatory teams for cross-TA support for guidance and best practice.
• Lead the establishment and maintenance of high-quality relationships with regional health authorities.
• Serve as the primary contact for health authorities for products within the portfolio.
• Contribute to regulatory assessments of changes in relevant regulations affecting CSL Behring's business in North America.
• Collaborate with regional commercial operations to ensure successful development and execution of regulatory strategies.
• Align regional strategies with the global regulatory strategy throughout the product lifecycle for assigned products.
• Facilitate comprehensive regulatory activities within GRA NA for assigned products.
• Represent GRA NA for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST).
• Negotiate with regional health authorities to achieve positive outcomes for CSL Behring.
• Lead US FDA meetings and utilize global GRA functions to support objectives.

Requirements

• Bachelor's degree in Science or Pharmacy is required.
• 10+ years of experience in the pharmaceutical industry in Biologics/Research & Development.
• 7+ years of experience in regulatory affairs, supported by additional pharmaceutical/industry experience.
• Direct regulatory-facing experience.
• Working knowledge of regulatory guidelines and legislative requirements for US FDA regulations.

Benefits

• Medical
• Dental
• Vision
• 401K
• Paid time Off