الصفحة الرئيسية United States Regulatory Manager, Advertising & Promotion
الصفحة الرئيسية United States Regulatory Manager, Advertising & Promotion
Regulatory Manager, Advertising & Promotion
تفاصيل الوظيفة
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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Advertising & Promotion', 'vacancies' => null, 'job_type_id' => null, 'description' => null, 'pay_status' => 'Free', 'external_job_description' => '<p> 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. </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. 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To prove this, all learning materials for each course are available for at least one year after the initial purchase.<br> <br> All of our tutors and IT help desk personnel are available to answer any questions regarding your training or any technical difficulties.<br> <br> <strong>Course Design</strong><br> <br> The course is delivered through our online learning platform, accessible through any internet-connected device. There are no formal deadlines or teaching schedules, meaning you are free to study the course at your own pace.<br> <br> You are taught through a combination of: <ul> <li>Video lessons</li> <li>Online study materials</li> </ul> <br> <strong>COURSE CURRICULUM</strong><br> <br> <strong>***Cooking and Chef Bundle***</strong><br> <br> 1# Higher Technician in Cooking and Gastronomy <ul> <li>Module 01: An Introduction to Gastronomy</li> <li>Module 02: Gastronomic Concepts</li> <li>Module 03: Thermal Processing of Food</li> <li>Module 04: Meat Preservation and Processing</li> <li>Module 05: Preservation and Processing of Fish</li> <li>Module 06: Culinary Techniques- Meat Preparation</li> <li>Module 07: Culinary Techniques-Fish Preparation</li> <li>Module 08: Physical, Chemical and Allergenic Hazards</li> <li>Module 09: Reopening and Adapting Your Food Business during COVID-19</li> </ul> 2# Level 2 Food Hygiene and Safety for Catering <ul> <li>Introduction to Food Safety and the Law</li> <li>Bacteria and Microbiological Hazards</li> <li>Physical, Chemical and Allergenic Hazards</li> <li>Food Poisoning and Control Measures</li> <li>Food Spoilage and Food Storage</li> <li>Personal Hygiene</li> <li>HACCP and Food Premises Part 01</li> <li>HACCP and Food Premises Part-02</li> <li>Cleaning</li> <li>Reopening and Adapting Your Food Business During COVID-19</li> </ul> 3# Italian Cooking <ul> <li>Module 1- The Perfect Soffritto</li> <li>Module 2- Fresh Tomato Sauce</li> <li>Module 3- Spaghetti with Fresh Tomato Sauce and Basil</li> <li>Module 4- Carbonara Spaghetti</li> <li>Module 5- The Original Pesto Sauce</li> <li>Module 6- Risotto with Saffron</li> <li>Module 7- Roasted and Baked Potatoes</li> <li>Module 8- Meatballs with Cherry Tomato Sauce</li> <li>Module 9- Milanese Steak</li> <li>Module 10- Caponata</li> <li>Module 11- Linguine with Fresh Clams</li> <li>Module 12- Spaghetti with Seafood and Shellfish</li> <li>Module 13- Octopus and Potato Salad</li> <li>Module 14- Baked Whole Fish in Crust Salt</li> <li>Module 15- Swordfish with Veggies and Tomato Sauce</li> <li>Module 16- Filet of Fish in Foil with Herbs and Potatoes</li> </ul> 4# Vegan Vegetarian Cooking <ul> <li>Lesson 1 – Getting Started Vegan Cooking</li> <li>Lesson 2 – Learning about ingredients</li> <li>Lesson 3 – Quick and Easy Breakfasts</li> <li>Lesson 4 – Hot Delicious Breakfasts</li> <li>Lesson 5 – Packed Sack Lunches</li> <li>Lesson 6 – Hot Lunches and Main Meals</li> <li>Lesson 7 – Simple Suppers</li> <li>Lesson 8 – Healthy Vegan Holidays 1</li> <li>Lesson 9 – Healthy Vegan Holidays 2</li> <li>Lesson 10 – Bread and Spreads</li> <li>Lesson 11 – Soup and Crackers</li> <li>Lesson 12 – Healthy Desserts</li> </ul> <strong>Vegan Vegetarian Cooking - Handouts<br> <br> Mock Exam<br> <br> Final Exam</strong><br> <br> <strong>Will I receive a certificate of completion?</strong><br> <br> Upon successful completion, you will qualify for the UK and internationally-recognised CPD accredited certification. 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Whatever your situation and requirements, One Education can supply you with professional teaching, gained from industry experts, and brought to you for a great price with a limited-time discount.<br> <br> One Education has been proud to produce an extensive range of best-selling courses, and <strong>Cooking and Chef Bundle</strong> is one of our best offerings. It is crafted specially to promote easy learning at any location with an online device. Each topic has been separated into digestible portions that can be memorised and understood in minimum time.<br> <br> Teaching and training are more than just a job for the staff at One Education; we take pride in employing those who share our vision for e-learning and its importance in today’s society. To prove this, all learning materials for each course are available for at least one year after the initial purchase.<br> <br> All of our tutors and IT help desk personnel are available to answer any questions regarding your training or any technical difficulties.<br> <br> <strong>Course Design</strong><br> <br> The course is delivered through our online learning platform, accessible through any internet-connected device. There are no formal deadlines or teaching schedules, meaning you are free to study the course at your own pace.<br> <br> You are taught through a combination of: <ul> <li>Video lessons</li> <li>Online study materials</li> </ul> <br> <strong>COURSE CURRICULUM</strong><br> <br> <strong>***Cooking and Chef Bundle***</strong><br> <br> 1# Higher Technician in Cooking and Gastronomy <ul> <li>Module 01: An Introduction to Gastronomy</li> <li>Module 02: Gastronomic Concepts</li> <li>Module 03: Thermal Processing of Food</li> <li>Module 04: Meat Preservation and Processing</li> <li>Module 05: Preservation and Processing of Fish</li> <li>Module 06: Culinary Techniques- Meat Preparation</li> <li>Module 07: Culinary Techniques-Fish Preparation</li> <li>Module 08: Physical, Chemical and Allergenic Hazards</li> <li>Module 09: Reopening and Adapting Your Food Business during COVID-19</li> </ul> 2# Level 2 Food Hygiene and Safety for Catering <ul> <li>Introduction to Food Safety and the Law</li> <li>Bacteria and Microbiological Hazards</li> <li>Physical, Chemical and Allergenic Hazards</li> <li>Food Poisoning and Control Measures</li> <li>Food Spoilage and Food Storage</li> <li>Personal Hygiene</li> <li>HACCP and Food Premises Part 01</li> <li>HACCP and Food Premises Part-02</li> <li>Cleaning</li> <li>Reopening and Adapting Your Food Business During COVID-19</li> </ul> 3# Italian Cooking <ul> <li>Module 1- The Perfect Soffritto</li> <li>Module 2- Fresh Tomato Sauce</li> <li>Module 3- Spaghetti with Fresh Tomato Sauce and Basil</li> <li>Module 4- Carbonara Spaghetti</li> <li>Module 5- The Original Pesto Sauce</li> <li>Module 6- Risotto with Saffron</li> <li>Module 7- Roasted and Baked Potatoes</li> <li>Module 8- Meatballs with Cherry Tomato Sauce</li> <li>Module 9- Milanese Steak</li> <li>Module 10- Caponata</li> <li>Module 11- Linguine with Fresh Clams</li> <li>Module 12- Spaghetti with Seafood and Shellfish</li> <li>Module 13- Octopus and Potato Salad</li> <li>Module 14- Baked Whole Fish in Crust Salt</li> <li>Module 15- Swordfish with Veggies and Tomato Sauce</li> <li>Module 16- Filet of Fish in Foil with Herbs and Potatoes</li> </ul> 4# Vegan Vegetarian Cooking <ul> <li>Lesson 1 – Getting Started Vegan Cooking</li> <li>Lesson 2 – Learning about ingredients</li> <li>Lesson 3 – Quick and Easy Breakfasts</li> <li>Lesson 4 – Hot Delicious Breakfasts</li> <li>Lesson 5 – Packed Sack Lunches</li> <li>Lesson 6 – Hot Lunches and Main Meals</li> <li>Lesson 7 – Simple Suppers</li> <li>Lesson 8 – Healthy Vegan Holidays 1</li> <li>Lesson 9 – Healthy Vegan Holidays 2</li> <li>Lesson 10 – Bread and Spreads</li> <li>Lesson 11 – Soup and Crackers</li> <li>Lesson 12 – Healthy Desserts</li> </ul> <strong>Vegan Vegetarian Cooking - Handouts<br> <br> Mock Exam<br> <br> Final Exam</strong><br> <br> <strong>Will I receive a certificate of completion?</strong><br> <br> Upon successful completion, you will qualify for the UK and internationally-recognised CPD accredited certification. You can choose to make your achievement formal by obtaining your PDF Certificate at an affordable cost.<br> <br> <strong>Why study this course?</strong><br> <br> It doesn’t matter if you are an aspiring professional or an absolute beginner; this course will enhance your expertise and boost your CV with critical skills and an accredited certification attesting to your knowledge.<br> <br> The <strong>Cooking and Chef Bundle</strong> is fully available to anyone, and no previous qualifications are needed to enrol. All One Education needs to know is that you are eager to learn and are over 16.<br> ', 'outline' => null, 'who_should_take_this_course' => null, 'career_path' => 'Chef,Cook,Kitchen Assistant/Cook,Vegetarian Food Cook,Vegetarian Cook,HEALTHY MEAL PLAN COOK', 'eligibility' => 'There are no specific prerequisites to enrol in this Cooking and Chef Bundle. 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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. 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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الشركة المعلنة عن الوظيفة
CSL Behring
-
Asbestos for Architects & Designers New Skills Academy88 درهم
1,098 درهممدة الدورة التدريبية: Upto 2 Hours -
Cooking and Chef Bundle One Education467 درهم
9,697 درهممدة الدورة التدريبية: Upto 24 Hours
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