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Regulatory Manager, Advertising & Promotion

Employer
CSL Behring
Location
King of Prussia, Pennsylvania
Start date
Nov 6, 2023

View more

Discipline
Marketing, Advertising, Regulatory
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

Job Description

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

#LI-Hybrid

About Us

Our Benefits

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.

About 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!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
Telephone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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