Job Description

The Opportunity

You will oversee publishing activities as they relate to regulatory affairs issues at CSL Behring. The ideal candidate should possess a bachelor\'s degree, although an advanced degree in Life Science (such as a PhD or MD) or Business (such as an MBA) or a related field is preferred. Additionally, the candidate should have at least 6 years of regulatory experience within the pharmaceutical industry, with a preference for experience in biologics regulatory affairs.

Reporting to the Global Submissions Production Team, provide leadership for the Local Publishing Team you will be responsible for the publishing of the assigned tasks, including Submission Compilation, Regulatory Operations and eCTD.

The Role

- You will create high-quality submission packages (i.e., e-CTD, NEES, Paper) related to drugs under investigation, marketing authorization applications, lifecycle management applications, and post approval applications (e.g., NDA, BLA, IND, CTA, PSUR, and Variations)

- Ensure that submissions are published observing health authority requirements.

- Support major submissions across the sites in close co-operation with the Global Publishing Lead

- Support the implementation and maintenance of global publishing systems (including system testing and validation) and processes.

- Ensure close collaboration with the relevant partners (e.g., Development Product and Established Product regulatory specialist, regional/local regulatory colleagues, source document authors)

- Monitor regulatory bodies on regulatory publishing requirements and brings these new requirements to the attention of the Global Publishing Committee. Implement these new publishing requirements and systems updates.

- Participate in the Global Publishing Committee, which is in charge of the coordination of all publishing work-sharing activities.

- Represent the GRA publishing function in GRAST meetings.

- You will develop training materials and SOPs/Work Instructions for GRA and authors of source documents and provides training,

- You will work with CSL Behring\xe2\x80\x99s IT department on publishing systems implementation and maintenance

- Take on additional tasks as requested by the Global Publishing lead or GRA management, e.g., Deputy of the Global Publishing Lead

- People Management:

• Organize, coordinate and manage the local team to meet business needs
• Coach and develop team members
• Performance evaluations of direct reports
• Support Regulatory Affairs staff in filing processes.
• Training and orientation of new publishing staff

Your experience

6 years industry regulatory experience, at least 4 years in a regulatory publishing function

Management experience with local teams.

Understand publishing practices and related issues. Direct hands-on experience with the successful submission of eCTD dossiers is an important requirement.

Familiarity with health authority dossier requirements of the main markets (e.g., EU, US, CA, CH, AU) and ICH guidelines on CTD /eCTD requirements

Experience with publishing systems and IT system validation and testing practices

Solid experience with electronic document management systems

Experience with Insight Publisher

Our Benefits

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our to see what\xe2\x80\x99s available to you as a CSL employee.

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 .

We want CSL to reflect the world around us

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

Do work that matters at CSL Behring!

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