Suada Celikovic

About Suada Celikovic

Accomplished regulatory operations leader with 22 years of progressive experience driving global submission strategy and execution across all stages of product development and commercialization. Expertise in leading high-performing teams, optimizing regulatory workflows, and ensuring compliance with global health authority requirements, including FDA and ICH guidelines. Proven track record in overseeing complex submission planning and eCTD publishing, managing global regulatory submissions (INDs, NDAs, BLAs, MAAs), and ensuring timely delivery in alignment with corporate and regulatory timelines. Deep experience with eCTD publishing tools, document management systems, and electronic archive solutions. Strong technical leadership in implementing and maintaining Regulatory Information Management (RIM) platforms, including Veeva Vault RIM. Respected for building collaborative partnerships across Regulatory Affairs, Clinical, CMC, NonClinical, Commercial, and Quality functions. Skilled in leading through change, building scalable infrastructure, and streamlining operations in high-growth and fast-paced environments. Strategic thinker with hands-on capability, exceptional problem-solving and decision-making skills, and a passion for operational excellence. Adept in all standard business software platforms. U.S. citizen with a long-standing commitment to quality, compliance, and team development.

Experience

1. Senior Director, Regulatory Operations

   Replimune

   Apr 2025 — Present

Skills

• Clinical Trials
• Regulatory Submissions
• Regulatory Documentation
• Validation
• Lifesciences
• CRO
• Document Management
• Capa
• Oncology
• 21 Cfr Part 11
• Biopharmaceuticals
• Ctms
• Technology Transfer
• Medical Devices
• Change Control
• Training
• Drug Discovery
• Ich-Gcp
• Pharmacology
• Clinical Data Management
• Quality System
• Immunology