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- Tasks: Lead advertising and promotion compliance for innovative therapies in a dynamic biotech environment.
- Company: Join CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Make a meaningful impact on patient lives while working with cutting-edge therapies.
- Qualifications: Bachelor's in Life Science and 3+ years in Regulatory or related fields required.
- Other info: Be part of a collaborative team driving innovation in healthcare.
The predicted salary is between 43200 - 72000 £ per year.
CSL is transforming its R&D organization to accelerate innovation and create greater impact for patients. With a streamlined, project-led structure and a focus on collaboration, we are building a future-ready team that excels in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
The job is in our King of Prussia, PA, Waltham MA, Zurich Switzerland or Maidenhead UK office. This is a hybrid position and is onsite three days a week. You will report to the Head, Global Advertising & Promotional.
Position PurposeProvide an overview of the responsibilities of the position by summarizing the most important aspects and duties:
- Ensure compliance with HA drug promotion and promotional labeling regulations for assigned licensed products.
- Review, approve, or reject promotional programming based on U.S. Code of Federal Regulations and FDA implementing regulations and guidance.
- Adhere to related SOPs and work instructions for established MCC/PRC processes.
- Review advertising and promotional labeling; comment, improve, approve, or reject material based on company practice, CSL policy, U.S. law, and FDA regulations.
- Collaborate with Commercial Operations Marketing, Legal, and Medical personnel to minimize HA enforcement risk while supporting CSL’s commercial success.
- Monitor and apply trends in advertising and promotional labeling regulations to CSL U.S. regional review practices and processes.
- Provide regulatory leadership and guidance to marketing during development, review, and approval of promotional materials for assigned therapeutic areas.
- Prepare and submit advertising and promotional labeling materials to the FDA as required under 21 CFR 314.81(b)(3)(i) or 21 CFR 601.45.
- Maintain technical biologics/medical knowledge for assigned therapeutic areas.
- Actively contribute to the global CSL regulatory community through designated projects and assignments.
- Review and advise product development teams on communication strategies or tactics regarding investigational products.
- Bachelor's Degree Life Science.
- Minimum 3 years in Regulatory, Medical, or Legal Affairs or other relevant experience.
- Skilled in implementing regulatory science and monitoring enforcement trends.
- Ability to read and comprehend product-related technical and medical information.
About CSL Behring: CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
Senior Manager US Advertising & Promotion Lead in Maidenhead employer: CSL
Contact Detail:
CSL Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager US Advertising & Promotion Lead in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to your connections in the biotech field, especially those who work at CSL or similar companies. A friendly chat can open doors and give you insider info on the hiring process.
✨Tip Number 2
Prepare for interviews by researching CSL's recent projects and initiatives. Show us that you're not just interested in the role but also passionate about our mission to make a difference in patients' lives.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the Senior Manager role. Highlight your regulatory knowledge and how it can benefit CSL’s advertising and promotional strategies.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows us you’re serious about joining our team.
We think you need these skills to ace Senior Manager US Advertising & Promotion Lead in Maidenhead
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Manager US Advertising & Promotion Lead role. Highlight your relevant experience in regulatory affairs and how it aligns with CSL's mission to innovate in biotech.
Showcase Your Knowledge: Demonstrate your understanding of advertising and promotional regulations in your application. Mention specific experiences where you've navigated compliance challenges, as this will show us you're ready to hit the ground running.
Be Clear and Concise: When writing your application, keep it straightforward. Use clear language and avoid jargon unless it's industry-specific. We appreciate a well-structured application that gets straight to the point!
Apply Through Our Website: We encourage you to submit your application through our official website. This ensures your application is seen by the right people and helps us streamline the process. Plus, it’s super easy!
How to prepare for a job interview at CSL
✨Know Your Regulations
Familiarise yourself with the U.S. Code of Federal Regulations and FDA guidelines related to drug promotion. Being able to discuss specific regulations and how they apply to CSL's products will show your expertise and readiness for the role.
✨Showcase Your Collaboration Skills
Prepare examples of how you've successfully collaborated with cross-functional teams in the past. Highlighting your experience working with marketing, legal, and medical personnel will demonstrate that you can navigate the complexities of regulatory compliance while supporting commercial success.
✨Stay Updated on Industry Trends
Research current trends in advertising and promotional labeling regulations. Being able to discuss recent changes or emerging trends during your interview will illustrate your proactive approach and commitment to staying informed in a dynamic biotech environment.
✨Demonstrate Technical Knowledge
Brush up on your technical knowledge related to biologics and medical information relevant to the therapeutic areas you'll be working with. Being able to articulate this knowledge will not only impress your interviewers but also show that you're ready to contribute from day one.
