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Job Description

CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we're building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next Director, Global Advertising and Promotion? The job is in our King of Prussia, PA office. This is a hybrid position and is onsite three days a week. You will report to the **Advertising & Promotional Labeling Lead, GRA Region North America**

Position Purpose

+ Provide an overview of the responsibilities of the position by summarizing the most important aspects and duties.

+ Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products.

+ Review, approve, or reject promotional programming based on U.S. Code of Federal Regulations and FDA implementing regulations and guidance.

+ Adhere to related SOPs and work instructions for established MCC/PRC processes.

Main Responsibilities and Accountabilities

+ Review advertising and promotional labeling; comment, improve, approve, or reject material based on company practice, CSL policy, U.S. law, and FDA regulations.

+ Collaborate with Commercial Operations Marketing, Legal, and Medical personnel to minimize HA enforcement risk while supporting CSL’s commercial success.

+ Monitor and apply trends in advertising and promotional labeling regulations to CSL U.S. regional review practices and processes.

+ Provide regulatory leadership and guidance to marketing during development, review, and approval of promotional materials for assigned therapeutic areas.

+ Prepare and submit advertising and promotional labeling materials to the FDA as required under 21 CFR 314.81(b)(3)(i) or 21 CFR 601.45.

+ Maintain technical biologics/medical knowledge for assigned therapeutic areas.

+ Actively contribute to the global CSL regulatory community through designated projects and assignments.

+ Review and advise product development teams on communication strategies or tactics regarding investigational products.

Experience

+ Bachelor's Degree Life Science

+ Minimum 3 years in Regulatory, Medical, or Legal Affairs or other relevant experience.

+ Skilled in implementing regulatory science and monitoring enforcement trends.

+ Ability to read and comprehend product-related technical and medical information.

\#LI-HYBRID

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 benefits site (https://www.cslbenefits.com/csl/candidates) to see what’s available to you as a CSL employee.

About CSL Behring

CSL Behring (http://cslbehring.com/) is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma (http://www.cslplasma.com) . Our parent company, CSL (https://www.csl.com/) , headquartered in Melbourne, Australia, employs 32,000 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 (https://www.csl.com/careers/inclusion-and-belonging) .

Do work that matters at CSL Behring!

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CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement