• Lead the planning, coordination, and execution of global regulatory submissions (e.g., INDs, CTAs, NDAs, BLAs, MAAs, and amendments), ensuring compliance with global regulatory requirements and timelines. • Provide operational oversight of eCTD submission activities, partnering with external publishing vendors and internal stakeholders to ensure high-quality, timely deliverables. • In partnership with the Senior Director of Regulatory Operations, play a key role in establishing internal publishing capabilities, including defining and leading implementation of publishing capability strategy • Ensure accurate maintenance of regulatory documentation, submission records, and data within regulatory information management and document management systems. • Oversee regulatory document management, tracking, and archival processes to ensure completeness, accuracy, and inspection readiness. • Serve as system administrator for regulatory systems (e.g., Veeva RIM) and act as the internal subject matter expert (SME), driving training, user adoption, and ongoing support in alignment with the defined system strategy and roadmap. • Ensure adherence to global submission standards, including eCTD structure, formatting, and publishing requirements. • Drive the development and continuous improvement of regulatory operations processes, tools, and best practices to enhance efficiency, quality, and consistency. • Lead, mentor, and develop a small team of regulatory operations staff, fostering a high-performing and collaborative team environment. • Oversee vendor relationships and outsourced publishing activities, ensuring performance, quality, and cost-effectiveness. • Partner with Regulatory Affairs leads to operationalize global submission strategies. • Collaborate cross-functionally with clinical, quality, and CMC teams to ensure alignment and execution of submission plans. • Monitor submission milestones and deliverables, proactively identifying risks and driving mitigation strategies to prevent delays. • Ensure ongoing compliance with global regulatory standards and organizational policies. • Maintain inspection readiness and support internal and external audits. • Ensure integrity, accuracy, and completeness of regulatory records and documentation. • Manage submission timelines, milestones, and deliverables across programs. • Lead risk assessment, escalation, and resolution to ensure successful execution of regulatory activities.

• Manages the planning, compilation, QC, and submission of Investigational Drug Applications (INDs), Biologics License Applications (BLAs), and their amendments. • Prepares routine IND and CTA amendments. • Work with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule. • Represents Regulatory Affairs and provides regulatory expertise to cross-functional teams on specified projects and topics. • Assists in developing and managing Gantt charts (in conjunction with Program Management) and trackers for submissions across the multiple products. • Maintains logs of IND and CTA submissions and correspondence with FDA or other regulatory agencies. • Prepares templates or shells for specific submissions based on company standards. • Perform miscellaneous duties as assigned.

• Collaborates closely with functional leaders to create the optimal development path for Iovance product candidates. • Negotiates optimal development paths within cross-functional teams and with health authorities. • Executes clinical-regulatory development plans on-time and while managing all identified risks. • Plans, manages, and creates Clinical Trial Applications, Market Applications, and amendments. • Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy. • Leads cross-functional teams in developing strategic briefing packages and in preparing for health authority meetings or interactions. • Ensures that evolving global regulations, guidelines, and health authority expectations are incorporated into program decision making. • Works within the department and with other functional areas on process improvements. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

Role Description Longbridge is excited to be adding to our Compliance Department. This newly created role, Mortgage Compliance Officer, will be responsible for researching compliance with all mortgage banking laws, rules, regulations, and prescribed policies/practices/procedures necessary to reduce risk and uphold ethical standards. - In-depth knowledge of state and federal consumer regulations, including but not limited to: - Licensing - TILA - HMDA - RESPA - UDAAP - Non-bank CRA requirements - SOX - Review regulatory changes and assess how the changes might affect the company. Provides recommendations about necessary policy and procedural changes. - Oversee monthly regulatory compliance weaknesses throughout the organization and work with management to identify root causes, remediation steps, and tracking of the issues. - Contribute to the compliance training program, which may include: - Identifying training courses, webinars, etc. - Creating compliance-related training and providing it through various methods. - Monitor federal and state regulatory sources (CFPB, HUD, TILA, HMDA, RESPA, UDAAP state agencies) for new rules, guidance, and legislative updates affecting mortgage lending. - Draft compliance alerts. - Maintain a regulatory change log and ensure all updates are documented, categorized, and escalated appropriately. - Summarize complex regulatory changes into clear, actionable summaries for operations, sales, and executive leadership. - Design and maintain spreadsheets and tracking tools to document changes made in the Loan Origination System (LOS), including version history and effective dates. - Prepare reports, presentations, and meeting materials for internal and external compliance reviews. - Assist in the implementation of compliance policies and procedures. - Respond to compliance-related inquiries from other departments within the company. - Reverse mortgage experience is a plus but not required. Qualifications - Bachelor’s degree is required with a minimum of five (5) years in a compliance role with a financial institution. - Knowledge in mortgage banking and consumer compliance laws and regulations. - Ability to form effective relationships and achieve influence at the most senior level in the organization. - Proactive, motivated, strong attention to detail, and proven track record in building good working relationships. - Ability to work independently as well as in a team environment. - An understanding of when issues require escalation. - Working knowledge of the Microsoft Office Suite of products. - Analytical writing skills along with strong verbal and written communication skills. Requirements - Working in a growing and dynamic industry. - Full benefits: Medical, Dental, Vision, FSA/HSA, and a wide array of voluntary products and discounts. - 401(k) with company match. - Paid time off. - This is an exempt role. - Target base salary range is $130K - $135K, based on various factors including skills and work experience. - Eligible for a competitive additional compensation program via annual bonus based on individual performance. - LBF is an EEO/AA/Vet/Disabled Employer. - Please note that salaries estimated on various job sites may not reflect the actual compensation.