Regulatory Affairs Director for North America

5 days ago

King of Prussia, United States CSL Behring Full time
Director, Global Regulatory Affairs - North America

Career Opportunities at CSL Behring.

We are committed to delivering medicines that improve the lives of millions of people worldwide. With operations in 35+ nations and ~ 30,000 employees globally, we are a global leader in protein biotherapeutics.

About the Job:

This role will be based in our King of Prussia, PA office and is a hybrid position. You will report to the Director of Global Regulatory Affairs.

Key Responsibilities:
  • Serving as a Delegate: Support cross-TA support for guidance and best practices within the GRA Region regulatory teams.
  • Establishing Relationships: Lead high-quality relationships with regional health authorities and collaborate with respective GRA Global Product Strategy (GPS) TA Leads & GRA CMC Site Leads.
  • Contribution to Regulatory Planning: Contribute to regulatory account planning for changes in relevant regulations/laws affecting CSL Behring's business within the Region North America.
  • Maintenance of Product Strategies: Ensure successful development, strategic agreement, and execution of regional regulatory strategies for assigned products.
What We Are Looking For:
  • A Bachelor's degree in Science or Pharmacy, required.
  • 10+ years of experience in the pharmaceutical industry in Biologics/Research & Development, some experience may be accounted for with an advanced degree.
  • 7+ years of experience in regulatory, supported by additional pharmaceutical/industry experience.
Benefits:
  • Medical, Dental Vision.
  • 401K.
  • Paid time Off.

$110,000 - $140,000 per annum.

The salary range includes non-monetary benefits and performance bonuses. Our comprehensive compensation package reflects our commitment to recognizing individual contributions while rewarding exceptional performance. As you progress through your career, you can expect to receive competitive increases in line with market standards.

Additional Information:

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. With a strong presence in over 100 countries, our treatments offer promise for people living with conditions in various therapeutic areas.

At CSL Behring, we believe in embracing diversity and inclusion. We welcome talented individuals from diverse backgrounds and strive to create an inclusive environment where everyone feels valued and empowered to contribute their unique perspectives and skills.

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