• Defining, coordinating and implementing global CMC regulatory strategies for product specific development and life-cycle activities • Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub-teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets • Liaising directly with the US FDA and with local regulatory teams for discussions with international health authorities and agencies for CMC-related matters • Negotiating with regulatory authorities during the development process to ensure submission acceptance and approval • Managing the CMC regulatory strategy of high quality and compliant regulatory CMC documentation (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives • Advising on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with business needs and goals • Facilitating the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders • Identifying and recommending the most effective CMC regulatory strategies to assure a first-pass regulatory approval of initial application and lifecycle supplements/variations • Collaborating with key functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs • In collaboration with the network strategist, developing and managing timelines supporting regulatory submissions, proactively identifying risks and developing adequate risk management solutions in consultation with cross-functional teams

• As the Director of Compliance (blend of Customs Compliance and Account Management), you will manage a remote-first team that supports a network of licensed customs broker partners and ABI users throughout the US and Canada to derive value from the platform. • Act as a knowledge leader in customs compliance as an escalation point for Internal Stakeholders: Operations, Customer Success, Sales, Marketing, Finance, Product and Engineering. • Supervise a team of Broker Partner Success (BPS) and Post-Entry Analysts remotely including coordination of weekend, holiday, and ongoing time zone coverage plans to support business continuity across the US and Canada. • Support pre- and post-entry activity including but not limited to, liaising with importers and broker partners for timely and accurate clearance, exception management audits, invoice/statement escalations, CBP/CBSA requests, and special projects such as tariff planning. • Manage PSCs/Protests tracking in the US and Corrections/Adjustments in Canada. • Ongoing (weekly, biweekly, monthly) meetings with the broker partners and ABI users. • Other duties that may arise through the normal course of business.

• Conduct IP geolocation investigations using internal and external data sources, assessing potential circumvention risks and documenting findings in accordance with audit and compliance standards. • Escalate complex or high-risk cases with clear rationale and supporting analysis. • Maintain high standards of quality and accuracy by ensuring all case decisions, supporting evidence, and actions are appropriately recorded within the case management system. • Contribute to ongoing governance, quality assurance, and operational improvement initiatives to strengthen the effectiveness of geofencing controls and processes. • Support remediation activities, control reviews, and investigations relating to geofencing controls and restricted-location risks. • Collaborate with cross-functional stakeholders, including Operations, Product and Business to support issue resolution and control enhancements.

• Investigating and resolving complaints against company policies and procedures and FCA regulatory guidelines • Help teammates to resolve breaches / errors & omissions • Ensure all incidents are logged and review as part of root cause analysis to look at trends. • Assist the team with internal & FCA reporting • Help manage oversight of appointed representatives and introducers • Review processes to ensure best practice is being followed and offer suggestions for improvement. • Review financial promotions to ensure compliant and not misleading