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🌟 CTA/IND Submission Lead – Submission Delivery Excellence (Investigational)
📍 Locations: Poznan (Poland) | Bengaluru (India) | Cairo (Egypt) | Mexico City (Mexico) | Mississauga (Canada)
🗂 Department: Regulatory
🆔 Job ID: 414674
📅 Posted On: February 13, 2025
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🏢 About the Role
GSK is seeking a CTA/IND Submission Lead – Submission Delivery Excellence (Investigational) to oversee end-to-end regulatory submission processes, ensuring compliance with investigational drug development standards. This role requires expertise in regulatory submissions, process optimization, and stakeholder collaboration to drive efficiency and excellence.
The position holder will act as a subject matter expert (SME) between Global Regulatory Operations (GRO) and Global Clinical Operations (GCO), influencing key decisions and harmonizing business strategies to ensure timely and high-quality submission deliveries for R&D projects.
If you are passionate about regulatory compliance, innovation, and driving impactful change in investigational drug development, this role is for you!
🎯 Key Responsibilities
🔹 Regulatory Submission Oversight
- Lead and execute CTA/IND submission strategies, ensuring compliance with regulatory standards.
- Manage the preparation and submission of Clinical Trial Applications (CTA), including EU & Non-EU submissions, amendments, End of Trial Notifications (EOTN), and study summaries.
- Oversee the compilation and delivery of submission packages, ensuring alignment with investigational drug development processes.
🔹 Stakeholder & Process Management
- Act as the liaison between regulatory teams and business units, ensuring seamless communication and coordination.
- Collaborate with Regulatory Affairs, Clinical, and R&D teams to ensure submission timelines align with business objectives.
- Implement automation and process improvements to enhance efficiency and reduce redundancies.
🔹 Compliance & Quality Assurance
- Ensure strict adherence to GSK’s Regulatory Systems, SOPs, Work Instructions, and compliance guidelines.
- Drive continuous improvement initiatives, eliminating unnecessary handovers and ensuring end-to-end accountability.
- Advocate for best practices in regulatory submission management, leveraging digital tools and data-driven insights.
🔹 Team Leadership & Training
- Mentor and train team members to maintain regulatory excellence and stay updated with evolving global submission requirements.
- Ensure adherence to Service Level Agreements (SLAs) and monitor team performance.
- Support regulatory staff with process training and continuous learning opportunities.
🏆 What We’re Looking For
✅ Educational Background: A degree in biological sciences, healthcare, or a related scientific field.
✅ Experience: Extensive pharmaceutical regulatory affairs experience, specifically in global submission requirements.
✅ Regulatory Knowledge: Strong understanding of global submission procedures and regulatory compliance standards.
✅ Leadership & Project Management: Ability to lead submission teams, manage multiple projects, and drive process improvements.
✅ Technical Skills: Proficiency in regulatory submission management tools and process optimization.
✅ Collaboration & Communication: Ability to work effectively in a matrix organization and coordinate across global teams.
🌍 Why Join GSK?
💼 Career Growth: Be part of a leading global biopharma company committed to innovation.
🛠 Hybrid Work Model: Enjoy the flexibility of 2-3 days of remote work per week.
🎁 Attractive Rewards: Competitive salary, performance bonuses, and recognition awards.
🛡 Comprehensive Benefits: Life insurance, pension plans, and private healthcare for you and your dependents.
💪 Wellness Perks: Sports memberships, wellness programs, and flexible work options.
📚 Continuous Learning: Access to mentorship, training programs, and online learning platforms.
🤝 Inclusive Culture: Work in a diverse, collaborative, and supportive environment where your contributions matter.
🔗 Join Us and Get Ahead Together!
At GSK, we are dedicated to advancing healthcare through cutting-edge science and technology. Our mission is to improve lives globally, and our people are at the heart of everything we do. If you’re ready to make an impact in regulatory affairs and contribute to innovative drug development, we’d love to hear from you!
🔹 Apply Now & Take the Next Step in Your Career! 🚀