Senior Director Regulatory Group Lead - Enabling Healthcare Technologies

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 Senior Director, Regulatory Lead-Enabling Healthcare Technologies at CSL Behring plays a crucial leadership role within the Global Regulatory Affairs (GRA) team. This position is responsible for leading the strategic vision and goals for the Enabling Healthcare Technologies Team, ensuring alignment with organizational objectives and promoting innovation across various therapeutic areas. The role involves guiding regulatory strategies for a diverse portfolio, fostering collaboration among teams, and representing the organization in regulatory discussions and meetings.

Responsibilities

• Provide strategic leadership to the EHT Team, encouraging two-way communication with GRA Teams and main TA partners.
• Collaborate with the GRA GPS Leadership Team and serve as a delegate to relevant EHT-related governance bodies.
• Represent CSL Behring as an EHT expert at regulatory agency meetings and scientific conferences.
• Guide and mentor direct reports to foster strategic risk-taking in regulatory strategy development.
• Promote team growth in expressing project science through a regulatory perspective using advanced technologies.
• Lead regulatory device due diligence and divestiture activities for the therapeutic area.

Requirements

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, engineering, or related life science.
• 15 years of experience in the biotech or pharmaceutical industry, with at least 10 years in Regulatory Affairs.
• 5 years of experience in Medical Device regulatory affairs.
• Experience in creating and building teams across multiple geographic locations.
• 7+ years of experience coordinating efforts across diverse teams while maintaining a unified vision.
• Knowledge of pharmaceutical/biological product development and regulatory requirements in multiple regions (EU, US, Japan).

Nice-to-haves

• Experience in a global regulatory environment across two or more geographic areas.

Benefits

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