• Support management of the planning, compilation, QC, and submission of CMC dossier content to clinical and commercial applications, and their amendments. • Prepare and adapt submission documents for use in global clinical and commercial submissions following eCTD specifications and market specific requirements. • May be responsible for independently planning and preparing routine clinical trial application related amendments and commercial submissions (e.g. Annual reports, DSUR, health authority queries). • Independently manages submission trackers for coordination of submissions across multiple products. • Maintains logs of clinical and commercial submissions and correspondence with FDA or other regulatory agencies. • Facilitate communication with Vendors/ CROs for planning and tracking of source documents to ensure high-quality IND, IND amendments, CTA, EU-CTR submissions are delivered in timely manner. • Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval and commercialization). • Works with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes. • Prepare and compile effective presentations for external and internal audiences as needed. • Create documents in accordance with eCTD specifications. • Perform miscellaneous duties as assigned.

• 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. • Interface with Quality Assurance, clinical manufacturing, commercial manufacturing and other stakeholders to further develop and maintain a robust change control program. • Work with cross-functional project teams to develop CMC regulatory strategy for product changes at all stages of development. • Work within the CMC Regulatory Affairs team to gain consensus on proposed changes. • Negotiate with internal stakeholders to ensure that proposed changes and submission content are aligned with ICH guidelines, country regulations and guidelines, and industry standards. • Participate in risk mitigation by proactively identifying risk, developing options and contingency plans. • 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. • Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics. • Perform miscellaneous duties as assigned.

• Support management of the planning, compilation, QC, and submission of CMC dossier content to clinical and commercial applications, and their amendments. • Prepare and adapt submission documents for use in global clinical and commercial submissions following eCTD specifications and market specific requirements. • May be responsible for independently planning and preparing routine clinical trial application related amendments and commercial submissions (e.g. Annual reports, DSUR, health authority queries). • Independently manages submission trackers for coordination of submissions across multiple products. • Maintains logs of clinical and commercial submissions and correspondence with FDA or other regulatory agencies. • Facilitate communication with Vendors/ CROs for planning and tracking of source documents to ensure high-quality IND, IND amendments, CTA, EU-CTR submissions are delivered in timely manner. • Support the implementation of regulatory strategy for assigned projects and programs for projects in all stages of development (IND through NDA/BLA approval and commercialization). • Works with submission authors and reviewers to ensure that source document planning is complete and that high-quality documents are approved on-schedule in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes. • Prepare and compile effective presentations for external and internal audiences as needed. • Create documents in accordance with eCTD specifications.

• Oversees Ethics Committee (EC), Regulatory Authority (RA), and other submissions to ensure compliance and timely delivery. • Provides leadership for assigned projects and regulatory support to project teams. • Prepares/reviews core packages and country packages for RA submission. • Prepares, manages, and tracks IRB/IEC submissions as primary point of contact. • Peer review of documents prepared by regulatory team colleagues. • Reviews regulatory documents created by subcontractors for quality before submission. • Acts as point of contact for regulatory bodies and local teams regarding submissions. • Reviews and prepares study-specific regulatory documents/forms. • Manages translations with vendors and oversees submission of SUSARs. • Participates in meetings, audits, and project-related activities. • Ensures TMF completeness through timely document submissions. • Provides leadership and management to direct reports, including goal setting and mentoring. • Participates in process improvement initiatives and other assignments as required.