Home United States Regulatory Manager, Advertising & Promotion
Home United States Regulatory Manager, Advertising & Promotion
Regulatory Manager, Advertising & Promotion
at CSL Behring
in
United States
Posted on January 9, 2024
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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Finally, you will learn how to maintain a hygienic environment for your valuable customers.<br> <br> <strong>What you will learn in Food Safety & Hygiene Management for Supervisor</strong> <strong>course :</strong> <ul> <li>Understand the roles and responsibilities of a food supervisor</li> <li>Enrich your knowledge of law and legislation regarding food safety</li> <li>Familiarise with the Food Safety Management System and HACCP</li> <li>Learn the skills to detect and prevent food contamination</li> <li>Know the strategies of hazard control</li> <li>Gain the skills for risk control and pest management</li> </ul> <strong>Course Highlights</strong> <ul> <li>The price is for the whole Certificate in Food Hygiene and Safety course including the final exam - no hidden fees</li> <li>Accredited Certificate upon successful completion at an additional cost</li> <li>Efficient exam system with instant results</li> <li>Track progress within own personal learning portal</li> <li>24/7 customer support via live chat</li> </ul> <br> <strong>COURSE CURRICULUM</strong><br> <br> <strong>Food Safety & Hygiene Management for Supervisor</strong> <ul> <li>Introduction to Food Safety</li> <li>Roles and Responsibilities of a Food Supervisor and Policies</li> <li>Laws and Legislation</li> <li>Introduction to Food Safety Management Systems (FSMS) and HACCP</li> <li>Implementation and Tools of FSMS</li> <li>Food Poisoning Causes</li> <li>Detecting and Preventing Contamination</li> <li>Hazard Control</li> <li>Food Poisoning in Detail and Illnesses</li> <li>Food Toxins and their Prevention</li> <li>Food Handling Risks and Practices</li> <li>Temperature Control</li> <li>Recording Temperatures</li> <li>Spoilt Food and its Prevention</li> <li>Design Aspects of Food Premises</li> <li>Waste Disposal, Cleaning and Disinfection</li> <li>Pest Management</li> <li>Training and Supervising Staff Effectively</li> </ul> <br> <strong>Certificate in Food Hygiene and Safety </strong>course has been given CPD and IAO accreditation and is one of the best-selling courses available to students valuable Certificate in Food Hygiene and Safety course is suitable for anyone interested in working in this sector or who simply wants to learn more about the topic.<br> <br> If you're an individual looking to excel within this field then <strong>Certificate in Food Hygiene and Safety</strong> is for you. 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It not only involves the presentation and preparation of delicious foods but also concerns <strong>Certificate in Food Hygiene and Safety</strong>. It is a great responsibility for restaurant owners to ensure a healthy and hygienic environment with nutritious food.<br> <br> The <strong>Certificate in Food Hygiene and Safety</strong> course teaches you about food hygiene and HACCP. Without clean premises, your restaurant can be shut down by the health service.<br> <br> The physical, chemical, and biological hazards faced in the food industry will be thoroughly explained in the <strong>Certificate in Food Hygiene and Safety</strong> course. Finally, you will learn how to maintain a hygienic environment for your valuable customers.<br> <br> <strong>What you will learn in Food Safety & Hygiene Management for Supervisor</strong> <strong>course :</strong> <ul> <li>Understand the roles and responsibilities of a food supervisor</li> <li>Enrich your knowledge of law and legislation regarding food safety</li> <li>Familiarise with the Food Safety Management System and HACCP</li> <li>Learn the skills to detect and prevent food contamination</li> <li>Know the strategies of hazard control</li> <li>Gain the skills for risk control and pest management</li> </ul> <strong>Course Highlights</strong> <ul> <li>The price is for the whole Certificate in Food Hygiene and Safety course including the final exam - no hidden fees</li> <li>Accredited Certificate upon successful completion at an additional cost</li> <li>Efficient exam system with instant results</li> <li>Track progress within own personal learning portal</li> <li>24/7 customer support via live chat</li> </ul> <br> <strong>COURSE CURRICULUM</strong><br> <br> <strong>Food Safety & Hygiene Management for Supervisor</strong> <ul> <li>Introduction to Food Safety</li> <li>Roles and Responsibilities of a Food Supervisor and Policies</li> <li>Laws and Legislation</li> <li>Introduction to Food Safety Management Systems (FSMS) and HACCP</li> <li>Implementation and Tools of FSMS</li> <li>Food Poisoning Causes</li> <li>Detecting and Preventing Contamination</li> <li>Hazard Control</li> <li>Food Poisoning in Detail and Illnesses</li> <li>Food Toxins and their Prevention</li> <li>Food Handling Risks and Practices</li> <li>Temperature Control</li> <li>Recording Temperatures</li> <li>Spoilt Food and its Prevention</li> <li>Design Aspects of Food Premises</li> <li>Waste Disposal, Cleaning and Disinfection</li> <li>Pest Management</li> <li>Training and Supervising Staff Effectively</li> </ul> <br> <strong>Certificate in Food Hygiene and Safety </strong>course has been given CPD and IAO accreditation and is one of the best-selling courses available to students valuable Certificate in Food Hygiene and Safety course is suitable for anyone interested in working in this sector or who simply wants to learn more about the topic.<br> <br> If you're an individual looking to excel within this field then <strong>Certificate in Food Hygiene and Safety</strong> is for you. It provides all the basic knowledge about food hygiene and safety is for you.<br> <br> <strong>Certificate in Food Hygiene and Safety</strong><strong> </strong>is a comprehensive course. We've broken this food hygiene and safety course down into several manageable modules which we believe will assist you to easily grasp each concept - from the fundamental to the most advanced aspects of the Certificate in Food Hygiene and Safety course. It really is a sure pathway to success.<br> <br> All our courses offer 3 months access and are designed to be studied at your own pace so you can take as much or as little time as you need to complete and gain the full CPD accredited qualification. And, there are no hidden fees or exam charges.<br> <br> We pride ourselves on having friendly and experienced instructors who provide full weekday support and are ready to help with any of your queries. So, if you need help, just drop them an email and await a speedy response.<br> <br> Furthermore, you can check the validity of your qualification and verify your certification on our website at any time.<br> <br> So, why not improve your chances of gaining professional skills and better earning potential.<br> <br> <br> <strong>Assessment and Certification</strong><br> <br> At the end of the <strong>Certificate in Food Hygiene and Safety</strong> course, you will be required to sit an online multiple-choice test. Your test will be assessed automatically and immediately so that you will instantly know whether you have been successful. After you have successfully passed the final exam, you will be able to order an Accredited Certificate of Achievement.<br> <br> <strong>Career Path</strong><br> <br> Not only does our CPD and CiQ accredited course look good on your CV, setting you apart from the competition, but it can also be used as a stepping stone to greater things. Further advance your learning, launch a new career or reinvigorate an existing one.<br> <br> On successful completion of this <strong>Certificate in Food Hygiene and Safety</strong> course, you have the potential to achieve an estimated salary of £50,000.<br> <br> The sky really is the limit.', 'outline' => '', 'who_should_take_this_course' => '', 'career_path' => 'Food Safety Hygiene,Food Safety Manager,Hygiene Officer,HACCP,Certificate in Food Hygiene and Safety,Food Safety Management Officer,Hygiene Management Officer,Food Safety and Hygiene Manager,Food Safety and hygiene Management Officer,Supervisor – Food Safety and Hygiene', 'eligibility' => '<ul> <li>Passion for learning</li> <li>Basic understanding of English</li> <li>Basic IT Knowledge</li> </ul> ', 'school' => 'Alpha Academy', 'keywords' => 'Food Safety,hygiene,Food Hygiene,Safety,Food Safety And Hygiene Management, Certificate in Food Hygiene and Safety', 'location' => 'Online', 'duration' => 'Upto 6 Hours', 'timing' => '', 'cost' => null, 'discount' => '95% Off for Laimoon Users!', 'eligibility_criteria' => '', 'job_matching_keywords' => ' Certificate in Food Hygiene and Safety', 'boosted' => '0', 'lang_code' => 'en', 'status' => 'active', 'auto_translated' => '0', 'objectives' => null, 'photo' => null, 'photo_cta' => null, 'video' => null ), 'Profile' => array() ), (int) 1 => array( 'Course' => array( 'id' => '146427', 'seeder_id' => '43', 'edited_seeder_id' => '43', 'edited_client_id' => '99998627', 'title' => 'Diploma in Crime Scene Investigation', 'external_link' => 'https://studyhub.org.uk/course/crime-scene-investigator/', 'objectives' => null, 'photo_cta' => null, 'photo' => null, 'length' => null, 'next_session' => null, 'schedules' => null, 'duration' => 'Upto 8 Hours', 'base_duration' => '0', 'timing' => 'Flexible', 'location' => 'Online', 'global_location_id' => '275', 'school' => 'StudyHub', 'logo' => null, 'certificate_diploma' => 'yes', 'image' => null, 'brochure_url' => null, 'video' => null, 'cost' => null, 'price' => '89', 'price_enquiry' => '0', 'course_status' => 'Paid', 'base_price' => '24', 'nondiscounted_base_price' => '480', 'currency' => 'AED', 'discount' => '95% Off for Laimoon Users!', 'free_trial_text' => null, 'laimoon_offer' => '1', 'summary' => 'Imagine stepping into a scene where every detail tells a part of a story—a story that could mean the difference between justice served and a mystery left unsolved. That’s the power you wield as a Crime Scene Investigator. This course takes you into the heart of forensic science, where the small details speak volumes, and the truth lies hidden in the evidence. You’ll learn to listen to those silent whispers and piece together the puzzle of each crime scene.<br /> <br /> With each module, you’ll gain not just knowledge, but the confidence to apply it, transforming scenes of chaos into maps that lead to the truth. From fingerprints to DNA, from the psychology of a criminal mind to the latest in digital forensics, you’ll be the one who can read the story that evidence tells. This isn’t just about learning; it’s about becoming a voice for the silent truths waiting to be told.<br /> <br /> By the end of this journey, you won’t just be carrying a certificate; you’ll carry the satisfaction of knowing that your skills could tip the scales of justice. You’ll stand for something larger than yourself—the certainty that no matter how clever the crime, science and dedication can bring the truth to light. This is your chance to make a difference, to be the one who solves the puzzle that brings closure to those waiting, hoping, and needing the truth.<br /> <br /> <strong>Learning Outcomes</strong> <ul> <li>Understand the evolution and structure of forensic science.</li> <li>Acquire skills in meticulous crime scene investigation procedures.</li> <li>Master techniques for collecting and securing physical evidence.</li> <li>Analyse and compare fingerprint evidence effectively.</li> <li>Conduct detailed bloodstain pattern analysis.</li> <li>Apply principles of DNA profiling in forensic investigations.</li> <li>Identify and classify various drugs through chemical analysis.</li> <li>Examine firearms and ballistics for investigative leads.</li> <li>Assess and identify questioned documents and forgeries.</li> <li>Uncover and process digital evidence in criminal cases.</li> <li>Explore the psychological aspects of criminal behaviour.</li> </ul> <strong>COURSE CURRICULUM</strong> <ul> <li>Module 01: Forensic Science: The History and Organisation</li> <li>Module 02: Crime Scene Investigation</li> <li>Module 03: Collecting and Packaging Physical Evidence</li> <li>Module 04: Fingerprints: Your Personal Signature</li> <li>Module 05: Bloodstain Analysis</li> <li>Module 06: DNA Analysis</li> <li>Module 07: Drug Analysis</li> <li>Module 08: Firearms Examination</li> <li>Module 09: Questioned Documents: Handwriting And Forgery Examination</li> <li>Module 10: Digital Evidence</li> <li>Module 11: Forensic Psychology: Delving into the Criminal Mind</li> </ul> <strong>Who is this course for</strong> <ul> <li>Aspiring crime scene investigators seeking foundational knowledge.</li> <li>Law enforcement personnel aiming to specialise in forensic evidence.</li> <li>Legal professionals interested in the nuances of forensic science.</li> <li>Science graduates pursuing a career in forensic analysis.</li> <li>Individuals passionate about understanding criminal investigation.</li> </ul> <strong>Why Choose This Course</strong> <ul> <li>Unlimited access to the course for a lifetime.</li> <li>Opportunity to earn a certificate accredited by the CPD Quality Standards and CIQ after completing this course.</li> <li>Structured lesson planning in line with industry standards.</li> <li>Immerse yourself in innovative and captivating course materials and activities.</li> <li>Assessments designed to evaluate advanced cognitive abilities and skill proficiency.</li> <li>Flexibility to complete the Course at your own pace, on your own schedule.</li> <li>Receive full tutor support throughout the week, from Monday to Friday, to enhance your learning experience.</li> <li>Unlock career resources for CV improvement, interview readiness, and job success.</li> </ul> <strong>Certification</strong><br /> <br /> Upon course completion, a written assignment test is available. 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That’s the power you wield as a Crime Scene Investigator. This course takes you into the heart of forensic science, where the small details speak volumes, and the truth lies hidden in the evidence. You’ll learn to listen to those silent whispers and piece together the puzzle of each crime scene.<br /> <br /> With each module, you’ll gain not just knowledge, but the confidence to apply it, transforming scenes of chaos into maps that lead to the truth. From fingerprints to DNA, from the psychology of a criminal mind to the latest in digital forensics, you’ll be the one who can read the story that evidence tells. This isn’t just about learning; it’s about becoming a voice for the silent truths waiting to be told.<br /> <br /> By the end of this journey, you won’t just be carrying a certificate; you’ll carry the satisfaction of knowing that your skills could tip the scales of justice. You’ll stand for something larger than yourself—the certainty that no matter how clever the crime, science and dedication can bring the truth to light. This is your chance to make a difference, to be the one who solves the puzzle that brings closure to those waiting, hoping, and needing the truth.<br /> <br /> <strong>Learning Outcomes</strong> <ul> <li>Understand the evolution and structure of forensic science.</li> <li>Acquire skills in meticulous crime scene investigation procedures.</li> <li>Master techniques for collecting and securing physical evidence.</li> <li>Analyse and compare fingerprint evidence effectively.</li> <li>Conduct detailed bloodstain pattern analysis.</li> <li>Apply principles of DNA profiling in forensic investigations.</li> <li>Identify and classify various drugs through chemical analysis.</li> <li>Examine firearms and ballistics for investigative leads.</li> <li>Assess and identify questioned documents and forgeries.</li> <li>Uncover and process digital evidence in criminal cases.</li> <li>Explore the psychological aspects of criminal behaviour.</li> </ul> <strong>COURSE CURRICULUM</strong> <ul> <li>Module 01: Forensic Science: The History and Organisation</li> <li>Module 02: Crime Scene Investigation</li> <li>Module 03: Collecting and Packaging Physical Evidence</li> <li>Module 04: Fingerprints: Your Personal Signature</li> <li>Module 05: Bloodstain Analysis</li> <li>Module 06: DNA Analysis</li> <li>Module 07: Drug Analysis</li> <li>Module 08: Firearms Examination</li> <li>Module 09: Questioned Documents: Handwriting And Forgery Examination</li> <li>Module 10: Digital Evidence</li> <li>Module 11: Forensic Psychology: Delving into the Criminal Mind</li> </ul> <strong>Who is this course for</strong> <ul> <li>Aspiring crime scene investigators seeking foundational knowledge.</li> <li>Law enforcement personnel aiming to specialise in forensic evidence.</li> <li>Legal professionals interested in the nuances of forensic science.</li> <li>Science graduates pursuing a career in forensic analysis.</li> <li>Individuals passionate about understanding criminal investigation.</li> </ul> <strong>Why Choose This Course</strong> <ul> <li>Unlimited access to the course for a lifetime.</li> <li>Opportunity to earn a certificate accredited by the CPD Quality Standards and CIQ after completing this course.</li> <li>Structured lesson planning in line with industry standards.</li> <li>Immerse yourself in innovative and captivating course materials and activities.</li> <li>Assessments designed to evaluate advanced cognitive abilities and skill proficiency.</li> <li>Flexibility to complete the Course at your own pace, on your own schedule.</li> <li>Receive full tutor support throughout the week, from Monday to Friday, to enhance your learning experience.</li> <li>Unlock career resources for CV improvement, interview readiness, and job success.</li> </ul> <strong>Certification</strong><br /> <br /> Upon course completion, a written assignment test is available. 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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. You will report to the Team Lead, Advertising & Promotion, GRA, Region North America </p><p></p><p><b> Responsibilities: </b></p><p></p><p> 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. </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. It’s important and so are you. Learn more about how we care at CSL. </p><p></p><h2><b> About CSL </b></h2><p> 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 . </p><p></p><h2><b> We want CSL to reflect the world around us </b></h2><p> As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. 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CSL Behring
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