- Provide strategic leadership for global regulatory strategies
- Oversee compliance for all CSL Plasma Inc Operations
- Act as a liaison for regulatory agencies
- Offer regulatory guidance for complex plasma fractionation changes
- Collaborate with global teams on regulatory strategies
- Support the development of regulatory infrastructure
- Participate in forums to stay updated on regulatory trends
- Develop programs to exceed regulatory requirements
- Degree in Biological Sciences or related health sciences
- 12+ years experience in pharmaceutical/health care industry
- 8+ years in Global Regulatory Affairs, Biologics Regulatory experience
- 10+ years leadership experience managing regulatory teams
- Global regulatory experience with knowledge of application submission processes
- (CMC) knowledge of regulatory framework in multiple regions (EU, US, Japan, China)
- Medical, Dental, Vision
- 401K
- Paid Time Off
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Lead for Global Regulatory Affairs, Plasma - King of Prussia, United States - CSL Behring
Description
About the Company:
CSL Behring is a leading biotechnology company dedicated to enhancing and saving lives worldwide. With a presence in over 35 countries and a team of 30,000 employees, CSL is focused on providing innovative therapies for rare and critical medical conditions.
Job Title:
CSL Plasma Lead for Global Regulatory Affairs, Plasma
Location:
King of Prussia PA, Holly Springs NC, Waltham MA, or Boca Raton office (Hybrid Role)
Job Description:
We are seeking an individual to join our team as the CSL Plasma Lead for Global Regulatory Affairs. In this role, you will play a key part in developing and executing global regulatory strategies to support CSL Plasma's initiatives. Your responsibilities will involve collaborating with external partners and health authorities to shape regulatory requirements and ensure compliance.
Responsibilities:
Experience
BENEFITS
Our Benefits
CSL offers comprehensive benefits to employees working at least 30 hours per week, ensuring the well-being of both employees and their families. From healthcare benefits to financial protection, CSL provides resources to support employees in every stage of life.
About CSL Behring
CSL Behring is dedicated to developing and delivering high-quality medicines for individuals worldwide facing rare and serious diseases across various therapeutic areas. Learn more about CSL Behring.
Inclusion and Diversity
CSL values diversity and inclusion across its global organization. Discover more about Diversity & Inclusion at CSL.
Make an Impact at CSL Behring
