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- Tasks: Lead the design and optimisation of platforms for pharmacovigilance and regulatory affairs.
- Company: CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Comprehensive benefits from day one, supporting your wellbeing and life goals.
- Why this job: Make a real impact in healthcare by enhancing safety and compliance processes.
- Qualifications: 12+ years in pharmacovigilance or regulatory affairs with strong leadership skills.
- Other info: Join a diverse team committed to innovation and patient care.
The predicted salary is between 43200 - 72000 ÂŁ per year.
Position Description Summary Acts as the operational interface for both pharmacovigilance (PV) and regulatory affairs teams, ensuring platform design, delivery, and operations support safety, compliance, and submission needs. This role will focus on optimizing platforms to streamline PV and regulatory processes, ensuring alignment with global standards and regulatory requirements. Main Responsibilities & Accountabilities •Serve as point of contact for both PV and regulatory platform design, delivery, and operations•Oversee the setup, integration, and ongoing governance of PV and regulatory platforms•Own and manage the PV and regulatory platform roadmap, ensuring it meets the evolving safety, regulatory, and compliance requirements•Lead cross-functional collaboration with clinical, IT, and external regulatory bodies to enhance platform adoption and submission efficiency•Manage platform optimization to support continuous compliance, efficiency, and scalability across both PV and regulatory domains•Drive process improvements and ensure that both PV and regulatory platforms are fully aligned with business and regulatory needs•Partner with the R&D and Enterprise Data, Automation and AI teams to advance the digital capabilities to transform the R&D Operating model Qualifications & Experience Requirements •Bachelor\’s or Master’s in Life Sciences, Regulatory Affairs, Health Informatics, or related field•12+ years of experience in pharmacovigilance, regulatory affairs, R&D operations, or platform management•Expertise in safety data systems, regulatory submission processes, and platform technologies•Proven leadership in managing cross-functional teams, projects, and vendor relationships•Strong knowledge of global regulatory requirements (e.g., FDA, EMA, MHRA) and safety data systems•Experience in PV system audits and inspections Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. 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. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Behring!
Senior Director, PV & Reg Platform Lead employer: CSL Behring
Contact Detail:
CSL Behring Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Director, PV & Reg Platform Lead
✨Network Like a Pro
Get out there and connect with people in the industry! Attend conferences, webinars, or local meetups related to pharmacovigilance and regulatory affairs. You never know who might have a lead on your dream job!
✨Showcase Your Expertise
When you get the chance to chat with potential employers, make sure to highlight your experience in platform management and cross-functional collaboration. Share specific examples of how you've optimised processes in the past to demonstrate your value.
✨Leverage LinkedIn
Keep your LinkedIn profile updated and engaging. Join relevant groups, share articles about the latest trends in regulatory affairs, and connect with professionals from CSL Behring. This can help you stay on their radar for future opportunities.
✨Apply Directly Through Our Website
Don’t forget to check out our careers page at CSL Behring! Applying directly through our website not only shows your interest but also gives you a better chance of being noticed by our hiring team. Let’s get you that Senior Director role!
We think you need these skills to ace Senior Director, PV & Reg Platform Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in pharmacovigilance and regulatory affairs. We want to see how your background aligns with the role, so don’t be shy about showcasing relevant projects and achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role and how your skills can help us optimise our platforms. Keep it engaging and personal – we love to see your personality come through.
Showcase Leadership Experience: Since this role involves managing cross-functional teams, make sure to highlight your leadership experience. Share specific examples of how you've led projects or teams in the past, and how that can benefit us at CSL Behring.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, you’ll find all the details you need about the position there!
How to prepare for a job interview at CSL Behring
✨Know Your Platforms
Make sure you have a solid understanding of the pharmacovigilance and regulatory platforms relevant to the role. Familiarise yourself with the latest technologies and how they optimise processes. This will show your potential employer that you're not just knowledgeable but also proactive about staying updated.
✨Showcase Your Leadership Skills
Prepare examples of how you've successfully led cross-functional teams in the past. Highlight specific projects where your leadership made a difference, especially in managing vendor relationships or driving process improvements. This will demonstrate your capability to handle the responsibilities of a Senior Director.
✨Understand Global Regulations
Brush up on global regulatory requirements like those from the FDA, EMA, and MHRA. Be ready to discuss how you've navigated these regulations in previous roles. This knowledge is crucial for ensuring compliance and will set you apart as a candidate who understands the bigger picture.
✨Prepare for Scenario Questions
Expect scenario-based questions that assess your problem-solving skills in real-world situations. Think about challenges you've faced in platform management or regulatory submissions and how you overcame them. This will help you illustrate your critical thinking and adaptability during the interview.