• Lead in the preparation and submittal of regulatory applications and on ‐ going application maintenance in accordance with established timelines and submission dates in compliance with local and global regulatory requirements for the different application types (eg, IND, NDA/BLA, MAA, CTA DMF). • Participate in project-planning meetings to provide input on submission timelines in collaboration with Manager, Regulatory Operations. • Ensure consistency across regulatory submission documents following the regulatory style guide (i.e. formatting, reviewing, and submissions). • Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents. • Conduct final review of published submissions to ensure consistency and compliance with regulatory requirements, as well as ensure metadata is correctly applied. • Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submissions. • Maintain compliance with current Good Manufacturing Practices (cGMPs), government regulations, industry standards, approved specifications, and Company procedures and directives while continuing to stay well-informed on future developments. • Actively participate in the development of Regulatory Operations processes (SOPs/GOPs, work instructions, checklist, templates) for preparing submissions and regulatory information management, in addition to assisting in the creation and maintenance of templates. • Work with Veeva RIM BA(s), subject matter experts, and cross functional departments to analyze and develop processes that support business needs using the Veeva Vault RIM suite (Submissions and Submissions Archive) • Develop global partnerships across the organization to help implement Regulatory Operations’ initiatives by attending and participating in Project Teams if deemed appropriate by manager. • Maintain knowledge of local and global regulatory submission requirements. • Assist in supporting Regulatory Operations’ technology including, but not limited to publishing tools, databases, and servers. • Ensure adherence to Company Standard Operating Procedures. • Mentor and support junior-level team members as needed to help facilitate the team’s growth. • Perform managerial activities in manager’s absence. • Other duties as assigned.

• Design and implement scalable assurance frameworks • translate abstract legislative requirements into concrete processes • act as a dedicated advisor to cross-functional partners • proactively identify gaps in platform risk management • serve as the primary point of contact for external audits • monitor evolving landscape of internet regulations • leverage advanced audit techniques to maximize compliance efficiency

• Develop personalized coach plans and provide regular coaching sessions with each team member to discuss performance and provide feedback on areas for improvement • Mentor and encourage a growth mindset amongst the team • Identify and recruit top-performing sales talent and manage performance and disciplinary challenges • Assess and set account territory priorities for the team • Develop and maintain accurate sales forecasts and regularly review and adjust sales plans and forecasts • Use data to monitor performance and identify trends or areas for improvement • Develop sales strategies and tactics that align with company goals and customer needs • Observe, assess and monitor seller outreach, deal pipeline and deal quality • Build strong relationships with internal peer teams and leadership to drive strong cross-organization success • Build relationships with external customers, prospects and partners, to support the go-to-market strategy • Encourage cross-functional collaboration to ensure the sales team has the support and resources they need to succeed • Foster a culture of teamwork and collaboration within the sales team to promote knowledge sharing and best practices • Encourage feedback and open communication to ensure all team members feel heard and valued, and to address any issues or concerns

• Establish Built-In Quality culture and deploy Zero Defect approaches across DAC engineering lifecycle • Develop and own DAC-specific quality processes, procedures, and engineering deliverables aligned with company standards • Lead Design FMEAs and Process FMEAs as core tools for proactive risk identification and mitigation • Integrate EHS and product safety requirements into DAC system design and engineering operations • Drive compliance and regulatory readiness by identifying relevant standards and requirements for DAC systems • Lead root cause analysis and corrective actions for design issues, test escapes, and field events • Partner across engineering, supply chain, and field execution to incorporate quality and compliance requirements • Plan and support internal audits, design reviews, and readiness reviews for DAC NPI projects • Enable culture change by championing Quality, EHS, and Compliance principles and coordinating training programs