Meg Gaj
Regulatory Operations Submission Manager @Apellis Pharmaceuticals
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WORK HISTORY
Regulatory Operations Submission Manager @Apellis Pharmaceuticals
Waltham, MA, US
EDUCATION
Carnegie Mellon University
BS, Information Systems
ABOUT MEG GAJ
Senior Manager, Global Regulatory Operations at Apellis Pharmaceuticals | Submissions Manager | Regulatory Systems & RIM Strategy | Veeva Vault RIM Publishing Expert Leveraging 15+ years of experience in the Healthcare and Life Sciences Industry, I specialize in ensuring submission readiness, regulatory compliance, and building scalable, system-enabled regulatory infrastructure. Key Skills:Veeva Vault Mastery: Proven track record in configuring, implementing and supporting Veeva Vault RIM solutions, focusing on Submissions, Publishing, and Submissions Archive.Regulatory Excellence: Adept at ensuring compliance with 21 CFR Part 11, and the entire System Development Life Cycle (SDLC), from planning to decommissioning legacy systems.Project Management: Successfully managing end-to-end publishing processes, providing clients with creative solutions to intricate business processes in the life sciences industry. Professional Experience:Current Role: As a Senior Manager at Apellis Pharmaceuticals I oversee end-to-end submission strategy and execution for investigational programs and support multiple global application initiatives. I am accountable for ensuring submission readiness, regulatory compliance, and operational alignment across cross-functional stakeholders. In addition, I support optimization of Regulatory Information Management (RIM) systems and publishing processes to ensure our regulatory operations infrastructure supports portfolio growth and evolving global requirements. Certifications: Certified in Veeva Vault Platform, Vault RIM with 4+ years experiencing configuring Vault Platforms, validating my proficiency in the field.🤝 Collaborative Approach: Thriving in collaborative environments, I foster strong relationships with project teams and clients to deliver tailored solutions. Vision: My vision is to contribute to the evolution of regulatory processes, seamlessly integrating technology to drive efficiency and compliance in the Healthcare and Life Sciences domain. Let’s Connect: Open to networking, collaboration, and discussing opportunities in the exciting intersection of technology and life sciences. Let\'s connect!
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