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
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
Medical, Dental Vision
Paid time Off
Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.
Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.
We want Seqirus to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.
Do work that matters at Seqirus!