Regulatory Science, Policy, and Intelligence Manager (GRAS)
Regulatory Science, Policy, and Intelligence Manager (GRAS)
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Job Description
CSLs R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration were building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
Position 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 CSLs 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 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
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.
Monitor analyze and share key regulatory trends and developments that could impact CSLs 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 CSLs 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.
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.
Maintain and further advance operational and process related activities within Regulatory Policy and Intelligence function.
Qualifications & Experience Requirements
Our Benefits
We encourage you to make your well-being a priority. Its important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring operates one of the worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 people and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL
Do work that matters at CSL Behring!
Required Experience:
Manager
Employment Type
Full-Time
