Regulatory Manager, Advertising & Promotion
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
Qualifications:
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 BENEFITS 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! Recommended Skills Biology Code Of Federal Regulations Product Design Medicine Labeling Consulting Estimated Salary: $20 to $28 per hour based on qualifications.
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
Qualifications:
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 BENEFITS 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! Recommended Skills Biology Code Of Federal Regulations Product Design Medicine Labeling Consulting Estimated Salary: $20 to $28 per hour based on qualifications.
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