Description
Summary
The primary purpose of this role is to support the Lead, EU, GRASP in advancement of regulatory science, policy and intelligence for EU region. This will be achieved in close collaboration with the Head of Global Regulatory Science & Policy, NA and APAC regional function leads, and internal global regulatory teams (e.g., shaping CSL positions), as well as through external engagement (e.g., enhancing CSL’s visibility and influence in the regulatory landscape). The incumbent will monitor and analyze regulatory trends, changes, and developments to inform strategic decision-making and maintain a competitive edge for CSL. In addition, the incumbent will maintain and enhance operational aspects of the role, including but not limited to the enhancement and maintenance of GRASP SharePoint and related processes.The scope of this role is intentionally broad and may evolve over time in response to shifting business priorities and emerging opportunities.
Main Responsibilities & Accountabilities
•Advance Regulatory Science, Policy, and Intelligence
Support the development of regulatory science, policy, and intelligence initiatives and contribute to shaping the regulatory environment for assigned platforms, business units, or topics. Help identify opportunities for non-product-specific collaboration with global health authorities. Collaborate with Global Regulatory Affairs (GRA), regional leads, and relevant teams to support the planning and execution of external engagement strategies. Represent CSL in select industry groups, professional associations, and other external forums, ensuring meaningful and well-prepared contributions. Provide regulatory science input for internal strategy discussions and help align regulatory policy goals with business objectives.
•Regulatory Intelligence & Communication
Monitor, analyze, and share key regulatory trends and developments that could impact CSL’s platforms or focus areas. Contribute to regular updates, reports, and other communications that support regulatory decision-making and knowledge sharing across the organization. Support assessments of new and draft regulations or guidance, contribute to CSL’s response and position, and align action plans with key stakeholders. Assist in identifying and prioritizing regulatory risks and opportunities, working closely with internal subject matter experts.
•Collaboration & Execution
Contribute to the development and tracking of the Regulatory Policy Roadmap and support measuring progress through KPIs.
Work with regional leads, internal regulatory teams, and other functions such as Public and Government Affairs (PAGA) to align efforts and share insights.
Engage with external partners or consultants, as needed, to support intelligence gathering and dissemination activities.
•Operations & Process
Maintain and further advance operational and process related activities within Regulatory Policy and Intelligence function.
Qualifications & Experience Requirements
•Bachelor’s degree in Life Sciences, Medical Science, Pharmacy, or a related field.•Minimum of 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 hands-on regulatory experience is preferred.•Familiarity with EU regulatory systems; additional global exposure is an advantage.•Experience contributing to regulatory intelligence or policy work is beneficial.•Previous interaction with regulatory agencies such as EMA is a plus.•Strong communication skills in English, both written and verbal, with the ability to present information clearly and concisely.•Proficiency with digital tools such as ChatGPT and Microsoft Copilot, along with a strong understanding of current AI trends, is preferred.•Demonstrates strategic thinking with a developing business awareness.•Collaborative mindset, with the ability to build effective working relationships and networks.•Proactive, adaptable, and comfortable working in a cross-functional, multicultural environment.•Willingness to travel internationally up to 20% of the time.
Our Benefits
We encourage you to make your well-being a priority. It’s important and so are you.