• Represents the Regulatory Affairs function in project teams and leads regulatory projects in accordance with established timelines to meet corporate objectives. • Develops and executes sound regulatory strategies to support business goals. • Oversees and ensures compliance with state, federal, and international medical device regulations and overall regulatory departmental objectives for new and existing products. • Assists with the training and mentoring of other Regulatory Affairs team members. • Represents RA department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate. • Evaluates possible pathways to marketing authorization and recommends pathway that appropriately weighs the probability of success with potential risks to the business. • Develops and executes sound regulatory strategies to support business goals with minimal oversight. • Assesses product and manufacturing changes and develops well-justified regulatory assessments for each global market. • Reviews and approves document change orders, advertising and promotional material, manufacturing nonconformances, technical documents, test protocols and reports, risk management documents, and labeling documents. • Directly interacts with regulatory bodies in the US and/or international regions to ensure projects remain on track and issues are resolved. • Develops, prepares, and submits high quality technical documentation/submissions for regulatory approval in the US and other international regions. • Establishes timelines, manages sub-team meetings relevant to regulatory processes, and ensures timely execution. • Prepares reports for management and develops metrics and proposals for regulatory process improvements.

• Develop global regulatory CMC strategies to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other submissions which include CMC information • Write and compile CMC sections of regulatory submissions including clinical trial applications and variations/supplements as well as registration submissions worldwide • Lead team of SMEs through extensive knowledge of eCTD requirements for Quality modules with respect to marketing authorization, post approval changes and clinical trial applications globally • Review data provided to support dossier preparation; identify gaps and risks and work with stakeholders to understand regulatory impact of the risks identified to aid with mitigation and informed decision making • Manage answers to questions from the Health Authorities in a timely and effective manner to ensure early approval • Interact and negotiate with Health Authorities on CMC issues • Develop and maintain project plans and schedules for CMC submissions • Evaluate proposed manufacturing changes for global impact assessments and provide regulatory strategies that support change implementation • Provide guidance on ICH, FDA, and EU CMC guidelines • Develop and maintain strong relationships with internal functional groups, contract manufacturing organizations and other relevant partners to ensure alignment of regulatory CMC strategies and successfully accomplish regulatory objectives • Represent the Regulatory Affairs CMC function on assigned cross-functional project teams • Ensure all CMC dossiers and relevant regulatory information are stored in Veeva according to Sobi’s guidelines

• Develop scalable and sustainable processes and tools for normalized controls, collecting audit evidence, monitoring controls, and conducting gap analyses. • Manage TRM’s existing security compliance and certification lifecycle (e.g., SOC 2 Type II, ISO 27001/27701, FedRAMP, CMMC) while planning for and prioritizing future compliance needs. • Operationalize the GRC program to maintain our regulatory certifications. • Manage customer due diligence requests including developing and maintaining security collateral for customers (e.g., SIG, CAIQ). • Conduct enterprise risk assessments and manage the risk registry. • Develop a vendor risk management program. • Identify areas for improvement based on input from customers, the go-to-market teams, and overall business objectives. Anticipate customer needs with respect to compliance and due diligence.

• Grow with an Ownership Mindset: We champion continuous learning and proactive innovation. Team members are encouraged to identify challenges and take ownership of initiatives that drive merchant, company and personal growth. By tackling complex problems and exploring creative solutions, you won’t just follow a playbook, you’ll be actively building the future of ShipBob. • Collaborate with Peers and Leaders Alike: ShipBob values collaboration and support, where team members and leaders alike are committed to helping each other succeed. We all set high standards and understand the importance of transparency at all levels. • Experience a High-Performance Culture and Clear Purpose: Our commitment to delivering results creates a goal-driven, high-performance culture where everyone is empowered to contribute to our mission with a clear understanding of their direct impact and accountability. • Merchant RFP & Questionnaire Automation • Own the end-to-end workflow for merchant RFPs, quality questionnaires, and compliance due diligence requests. • Validate AI-generated and system-drafted responses against approved source of truth documentation. • Identify net new, ambiguous, or high-risk questions and escalate them to designated compliance or legal policy owners. • Track and document exceptions, decisions, and approvals to maintain a defensible audit trail. • Partner with Product and Engineering to design and implement AI-assisted and rules-based automation for compliance workflows.