Senior Global Regulatory Project Manager

Senior Global Regulatory Project Manager (Reg PM)

The Senior Global Regulatory Project Manager (Reg PM) is responsible for the delivery of Global Regulatory activities from product development and capital projects (product/project GRASTs) of strategic importance to our product portfolio and Global Regulatory Affairs (GRA) improvement projects following the GRA strategy.

You will report into the Global Regulatory Project Management Lead where you will manage the coordination of regulatory submissions as defined in the Global Submission Management process and management of global, cross-functional Global Regulatory Affairs Strategy Teams (GRASTs) across CSL’s product portfolio.

The Senior Global Regulatory Project Manager ensures that the assigned regulatory submissions are planned, coordinated, monitored, tracked, and reported and that project/product GRASTs are managed and executed.

Responsibilities

• Responsible for initiation, planning, monitoring and closure of regulatory projects (i.e., product/project GRASTs and improvement projects) while adhering to budget, scope, and schedule requirements.
• Provide Regulatory PM for cross-functional Regulatory teams, which includes preparation, maintenance, and administration of core documentation, building and maintaining project schedules, charts and providing management reports.
• Strive for efficiency by ensuring consistent approaches and development of best practices. Provide feedback to the Global Submission Management Process team and GRAST teams to support continuous improvement.
• Collaborate with the different submission team members on global, regional, and local level to identify areas of improvement and implement necessary measures.
• Advocate for compliant application of the Global Submission Management Process and accurate use of the systems related to it.

This is an individual contributor role.

Qualifications

• Bachelor’s degree or equivalent in Life Science, Business, or similar degree
• 7+ years’ experience in the biotechnology or pharmaceutical industry (biologics regulatory experience and experience in a similar role preferred).
• In-depth knowledge in drug development and manufacturing processes for pharmaceuticals (from a regulatory perspective).
• 5+ years’ experience as a project manager leading project teams in a matrixed, global environment, including those with complex technical, geographic, or regulatory elements.
• Demonstrated experience leading cross-functional teams and delivering projects to meet business objectives on time, within budget

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

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