Manager, US Advertising & Promotion Lead 

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.

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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’s available to you as a CSL employee.

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, . Our parent company, , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

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 .