Senior Manager, Regulatory Science, Policy, and Intelligence
CSL
full-time
Posted on:
Location: Washington • 🇺🇸 United States
Visit company websiteJob Level
Senior
About the role
- Provide strategic and operational support to the Lead for North America, Regulatory Science, Policy, and Intelligence in advancement of regulatory science, policy, and intelligence.
- Monitor regulatory trends, changes, and developments to inform strategic decision-making and maintain a competitive edge for CSL.
- Maintain GRASP SharePoint and GRASP related processes.
- Help develop regulatory science, policy, and intelligence programs; shape regulatory environment for assigned platforms.
- Identify opportunities for non-product-specific collaboration with global regulatory authorities.
- Collaborate with Global Regulatory Affairs, therapeutic areas, regional leads, and teams to support planning external engagement strategies.
- Monitor and share important regulatory trends and developments that could affect CSL's platforms or focus areas.
- Contribute to regular updates, reports, and other communications that support regulatory decision-making and knowledge sharing.
- Contribute to development and tracking of the Regulatory Policy Roadmap and measure progress through Indicators.
- Work with regional leads, internal regulatory teams, and Public and Government Affairs (PAGA) to align efforts and share insights.
- Facilitate the process for assessing draft global regulations and regulatory guidelines, their potential impacts, propose CSL position and action plan with Head of Global Regulatory Science & Policy.
- Collaborate with global regulatory functions, CSL PAGA, other Intelligence groups to stay informed about changes in North America regulatory environment.
- Identify global topics for surveillance and advocacy.
Requirements
- Bachelor's degree in life sciences, PharmD, JD, or PhD preferred
- 3+ years of experience in the life sciences industry, with exposure to regulatory affairs or a related function
- Understanding of regulatory requirements across product development and post-marketing phases; prior firsthand regulatory experience
- Familiarity with US regulatory systems; additional global exposure
- Experience contributing to regulatory intelligence or policy work is beneficial
- Previous interaction with regulatory agencies such as FDA is a plus