Senior Manager, Regulatory Science, Policy, and Intelligence - Remote

Overview

CSL Behring is seeking a Senior Manager in Regulatory Science, Policy, and Intelligence to provide strategic and operational support in advancing regulatory science and policy within a global biotechnology organization.

In Short

• Provide strategic support to the Head of Global Regulatory Science.
• Monitor regulatory trends and developments.
• Enhance and maintain GRASP SharePoint and related processes.
• Develop regulatory science programs and shape regulatory environments.
• Collaborate with global regulatory teams and therapeutic areas.
• Contribute to regulatory decision-making and knowledge sharing.
• Facilitate assessment of global regulations and guidelines.
• Support planning of external engagement strategies.
• Contribute to the development of the Regulatory Policy Roadmap.
• Engage with regulatory agencies and stakeholders.

Requirements

• Bachelor's degree in life sciences, PharmD, JD, or PhD preferred.
• 3+ years of experience in the life sciences industry.
• Understanding of regulatory requirements in product development.
• Familiarity with US regulatory systems.
• Experience with regulatory intelligence or policy work.
• Previous interaction with regulatory agencies such as FDA is a plus.

Benefits

• Medical, Dental, Vision coverage.
• 401K plan.
• Paid time off.
• Benefits effective from day 1 for employees working at least 30 hours/week.
• Resources for mental health and financial protection.
• Support for family planning and emergency care.