• Proactively manages regulatory aspects of clinical studies in early-to-late development to create high quality regulatory submissions that support product development strategy. • Author and review Clinical modules of applications and amendments for submission, ensuring complete regulatory content that meets current regional requirements. • Represent Clinical Regulatory Affairs on cross-functional project teams. • Evaluate proposed clinical protocol changes for impact to existing filings and provide strategic regulatory guidance for optimal implementation of changes. • Establish and implement internal regulatory processes, author and review SOPs and Work Instructions. • Coordinate, track, and prioritize regulatory activities and associated resources, ensuring they are functional, consistent, and integrated to reflect cross-functional dependencies. • Determine risk assessment and implement regulatory strategies for products in early-to-late development. • Ensure regulatory compliance with relevant regulations.