CSL
Associate Director Global Regulatory Lead - EHT
CSL, King Of Prussia, Pennsylvania, United States, 19406
Overview
Associate Director Global Regulatory Lead - EHT at CSL. Location: King of Prussia, PA or Zurich, Switzerland. Hybrid position onsite three days a week. Reports to the Executive Director Head Regulatory. CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we are building a future-ready team that excels in dynamic biotech ecosystems. This role focuses on enabling healthcare technologies (EHT), encompassing complex medical devices with clinical development, software as a medical device and companion diagnostics. Responsibilities
Regulatory leaders who develop a global, integrated regulatory strategy with a patient-centric focus, leveraging business insights and prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Serve as the key GRA representative for Product Strategy Teams (PST) and related global R&D/commercial teams; lead the Global Regulatory Affairs Strategy Team (GRAST) to ensure connectivity and a unified regulatory voice across partners. Direct health authority interactions in the home country and with global authorities (FDA, EMA and others); maintain productive relationships and drive positive regulatory outcomes. Engage GRAST members to achieve regulatory deliverables, assign tasks, foster accountability and act as regulatory decision maker for GRAST/GRA project deliverables; promote effective communication between GRAST and R&D teams. Lead GRA project deliverables (e.g., Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and mentor GRAST members. Utilize GRAST, competitive regulatory intelligence, analytics and specialized regulatory functions (e.g., device/combination products) to deliver Global Regulatory Strategy Outlines for portfolio. Promote consistency and shared learnings across Global Regulatory Strategy; maintain relationships with GRAST members and GRAS Regions, including Regulatory CMC. Qualifications & Experience
Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science; advanced degree (MS, PhD, MD, DVM) or MBA preferred. Minimum of 10 years in biotech/pharma with at least 5 years regulatory experience; 3 years on developmental products. Experience leading teams (direct or matrix) for at least 3 years; ability to set direction, hold people accountable and foster collaboration. Knowledge of pharmaceutical/biological product development and regulatory requirements in multiple regions (EU, US, Japan). Experience in Regulatory Affairs with direct agency interaction responsibility with at least one health authority. Experience in a complex, matrix environment; ideal candidates will have a strong clinical or device foundation. Our Benefits
CSL employees who work at least 30 hours per week are eligible for benefits effective day 1. Benefits cover health care, financial protection and resources to support well-being and work-life needs. Review the benefits site for details. About CSL Behring
CSL Behring is a global biotherapeutics leader focused on immunology, hematology, cardiovascular/metabolic, respiratory and transplant therapies. We discover, develop and deliver innovative therapies using plasma fractionation, recombinant protein technology, and cell and gene therapy platforms. CSL Behring operates CSL Plasma; the parent company CSL employs 32,000 people and serves patients in more than 100 countries. Inclusion & Belonging
Inclusion and Belonging is at the core of our mission and who we are. By celebrating differences and fostering curiosity and empathy, we aim to better understand and connect with patients and donors, sustain a diverse workforce, and move our company forward. Job Details
Seniority level: Not Applicable Employment type: Full-time Job function: Legal Referrals increase your chances of interviewing at CSL. Get notified about new Legal Director jobs in King of Prussia, PA.
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Associate Director Global Regulatory Lead - EHT at CSL. Location: King of Prussia, PA or Zurich, Switzerland. Hybrid position onsite three days a week. Reports to the Executive Director Head Regulatory. CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we are building a future-ready team that excels in dynamic biotech ecosystems. This role focuses on enabling healthcare technologies (EHT), encompassing complex medical devices with clinical development, software as a medical device and companion diagnostics. Responsibilities
Regulatory leaders who develop a global, integrated regulatory strategy with a patient-centric focus, leveraging business insights and prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Serve as the key GRA representative for Product Strategy Teams (PST) and related global R&D/commercial teams; lead the Global Regulatory Affairs Strategy Team (GRAST) to ensure connectivity and a unified regulatory voice across partners. Direct health authority interactions in the home country and with global authorities (FDA, EMA and others); maintain productive relationships and drive positive regulatory outcomes. Engage GRAST members to achieve regulatory deliverables, assign tasks, foster accountability and act as regulatory decision maker for GRAST/GRA project deliverables; promote effective communication between GRAST and R&D teams. Lead GRA project deliverables (e.g., Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and mentor GRAST members. Utilize GRAST, competitive regulatory intelligence, analytics and specialized regulatory functions (e.g., device/combination products) to deliver Global Regulatory Strategy Outlines for portfolio. Promote consistency and shared learnings across Global Regulatory Strategy; maintain relationships with GRAST members and GRAS Regions, including Regulatory CMC. Qualifications & Experience
Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science; advanced degree (MS, PhD, MD, DVM) or MBA preferred. Minimum of 10 years in biotech/pharma with at least 5 years regulatory experience; 3 years on developmental products. Experience leading teams (direct or matrix) for at least 3 years; ability to set direction, hold people accountable and foster collaboration. Knowledge of pharmaceutical/biological product development and regulatory requirements in multiple regions (EU, US, Japan). Experience in Regulatory Affairs with direct agency interaction responsibility with at least one health authority. Experience in a complex, matrix environment; ideal candidates will have a strong clinical or device foundation. Our Benefits
CSL employees who work at least 30 hours per week are eligible for benefits effective day 1. Benefits cover health care, financial protection and resources to support well-being and work-life needs. Review the benefits site for details. About CSL Behring
CSL Behring is a global biotherapeutics leader focused on immunology, hematology, cardiovascular/metabolic, respiratory and transplant therapies. We discover, develop and deliver innovative therapies using plasma fractionation, recombinant protein technology, and cell and gene therapy platforms. CSL Behring operates CSL Plasma; the parent company CSL employs 32,000 people and serves patients in more than 100 countries. Inclusion & Belonging
Inclusion and Belonging is at the core of our mission and who we are. By celebrating differences and fostering curiosity and empathy, we aim to better understand and connect with patients and donors, sustain a diverse workforce, and move our company forward. Job Details
Seniority level: Not Applicable Employment type: Full-time Job function: Legal Referrals increase your chances of interviewing at CSL. Get notified about new Legal Director jobs in King of Prussia, PA.
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