CSL - King of Prussia, PA
posted about 2 months ago
Full-time - Senior
Hybrid - King of Prussia, PA
10,001+ employees
Ambulatory Health Care Services
About the position
The Associate Director, Global Regulatory Affairs at CSL Behring plays a crucial role in supporting the regulatory strategies for the North America region. This position involves collaboration with various teams to ensure compliance with regulatory requirements, maintain relationships with health authorities, and contribute to the global regulatory strategy for biotherapeutics. 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.
- Ensure collaboration with regional commercial operations for successful regulatory strategies.
- Align regional strategies with the global regulatory strategy throughout the product lifecycle.
- Guide regulatory activities within GRA NA for assigned products.
- Represent GRA NA in the Global Regulatory Affairs Strategy Team (GRAST).
- Accountable for CSL Behring's relationship with health authorities in the region.
- 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, with direct regulatory-facing experience.
- Working knowledge of regulatory guidelines and legislative requirements for US FDA regulations.
Benefits
- Medical, Dental, Vision
- 401K
- Paid time Off
