Home United States Regulatory Manager, Advertising & Promotion
Home United States Regulatory Manager, Advertising & Promotion
Regulatory Manager, Advertising & Promotion
Job details
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Regulatory Manager, Advertising and Promotion? This position is located in our King of Prussia PA. It is a Hybrid role. You will report to the Team Lead, Advertising & Promotion, GRA, Region North America Responsibilities: You will have principal accountability: ensure compliance with health authority drug promotion and promotional labeling regulations for assigned licensed products. Review or reject promotional programming based on US Code of Federal Regulations, FDA's implementing regulations and guidelines established by Health Canada. Follow related SOPs and work instructions for established internal processes.
- Review advertising and promotional labeling; comment, improve, approve, or reject material based on established company practice, CSL Policy, US Law and the FDA's implementing regulations
- Collaborate with Commercial Operations Marketing, Legal & Medical personnel to minimize/mitigate health authority enforcement risk while also advancing CSL's commercial success
- Provide regulatory guidance to the marketing team during the development and approval of product promotional programming/materials for assigned Therapeutic Areas
- Prepare and submit advertising and promotional labeling materials to the FDA under 21 CFR 314.81(b)(3)(i)
- As assigned, review and advise product development teams' communication strategies regarding investigational products
- Maintain technical biopharmaceutical/medical knowledge for assigned therapeutic areas
- Bachelor's degree in a Life Science or Business Advanced degree in a Life Science
- 1+ years regulatory experience in promotional labeling review and OPDP/CDER/FDA submission experience
- Medical, Dental Vision
- 401K
- Paid time Off
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
CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL .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.Do work that matters at CSL!
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Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. </p><p></p><p> With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. </p><p></p><p> Could you be our next Regulatory Manager, Advertising and Promotion? This position is located in our King of Prussia PA. It is a Hybrid role. 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Follow related SOPs and work instructions for established internal processes. </p><ul><li><p> Review advertising and promotional labeling; comment, improve, approve, or reject material based on established company practice, CSL Policy, US Law and the FDA's implementing regulations </p></li><li><p> Collaborate with Commercial Operations Marketing, Legal & Medical personnel to minimize/mitigate health authority enforcement risk while also advancing CSL's commercial success </p></li><li><p> Provide regulatory guidance to the marketing team during the development and approval of product promotional programming/materials for assigned Therapeutic Areas </p></li><li><p> Prepare and submit advertising and promotional labeling materials to the FDA under 21 CFR 314.81(b)(3)(i)</p></li><li><p> As assigned, review and advise product development teams' communication strategies regarding investigational products </p></li><li><p> Maintain technical biopharmaceutical/medical knowledge for assigned therapeutic areas </p><p></p></li></ul><p><b> Qualifications: </b></p><ul><li><p> Bachelor's degree in a Life Science or Business Advanced degree in a Life Science </p></li><li><p>1+ years regulatory experience in promotional labeling review and OPDP/CDER/FDA submission experience </p></li></ul><p><b> BENEFITS </b></p><ul><li><p> Medical, Dental Vision </p></li><li><p>401K </p></li><li><p> Paid time Off </p></li></ul><p>#LI-Hybrid </p><p></p><h2><b> Our Benefits </b></h2><p> We encourage you to make your well-being a priority. 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Smoking is harmful to human health and causes various critical diseases. With effects ranging from the risk of developing heart disease and lung cancer to stroke, smoking is detrimental to humans.<br /> <br /> Even so, people still continue to smoke and harm their health with nicotine found in tobacco. They become addicted to smoking and destroy their lives. It then becomes important to learn how to stop smoking, and this is what this course is all about.<br /> <br /> We first discuss smoking and its harmful effects on human health. We provide statistics on how much smoking affects human health, often leading to death.<br /> <br /> Next, we give the various benefits of stopping smoking. The range of benefits can act as motivating factors to help smokers quit the harmful habit.<br /> <br /> The course covers various facets of quitting smoking. It explains the need to set a quit date and how to prepare for it. 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This comprehensive Noise and Hearing Protection Practice training program is your ultimate guide to a successful career in this field. Whether you're a seasoned professional seeking to refine your expertise or a newcomer eager to jumpstart your career, Noise and Hearing Protection Practice Online Training has everything you need to excel.<br /> <br /> <strong>With this Noise and Hearing Protection Practice course, you will get a CPD-accredited PDF certificate and our exclusive student ID card absolutely free.</strong><br /> <br /> In this Noise and Hearing Protection Practice, you'll master the core skills of this sector, transforming from novice to confident expert. You will learn from industry experts, ensuring this immersive programme will ignite your creativity and fuel your problem-solving prowess with interactive exercises. And the reward? A coveted CPD-accredited certificate to showcase your newfound expertise. 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Follow related SOPs and work instructions for established internal processes. </p><ul><li><p> Review advertising and promotional labeling; comment, improve, approve, or reject material based on established company practice, CSL Policy, US Law and the FDA's implementing regulations </p></li><li><p> Collaborate with Commercial Operations Marketing, Legal & Medical personnel to minimize/mitigate health authority enforcement risk while also advancing CSL's commercial success </p></li><li><p> Provide regulatory guidance to the marketing team during the development and approval of product promotional programming/materials for assigned Therapeutic Areas </p></li><li><p> Prepare and submit advertising and promotional labeling materials to the FDA under 21 CFR 314.81(b)(3)(i)</p></li><li><p> As assigned, review and advise product development teams' communication strategies regarding investigational products </p></li><li><p> Maintain technical biopharmaceutical/medical knowledge for assigned therapeutic areas </p><p></p></li></ul><p><b> Qualifications: </b></p><ul><li><p> Bachelor's degree in a Life Science or Business Advanced degree in a Life Science </p></li><li><p>1+ years regulatory experience in promotional labeling review and OPDP/CDER/FDA submission experience </p></li></ul><p><b> BENEFITS </b></p><ul><li><p> Medical, Dental Vision </p></li><li><p>401K </p></li><li><p> Paid time Off </p></li></ul><p>#LI-Hybrid </p><p></p><h2><b> Our Benefits </b></h2><p> We encourage you to make your well-being a priority. 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Hiring company
CSL Behring
-
How to Stop Smoking Certification Courses Distance Learning Ltd.AED 184
AED 367Duration: Upto 1 Hour -
Noise and Hearing Protection Academy for Health & FitnessAED 46Duration: Upto 4 Hours
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