Role Description We are seeking a Senior Director, Head of Regulatory CMC with deep expertise in biological and cell therapy products and CMC regulatory requirements. This role will lead strategy, compliance, and submissions for complex manufacturing processes and report to the Chief Regulatory Officer. - Generate, review, and approve regulatory submissions associated with CMC. - Lead and manage the RA CMC team; mentor RA CMC team members. - Develop current and long-term strategies and objectives for regulatory CMC, that align with overall company strategy and seek approval from executive leadership and implement strategic plans in collaboration with Manufacturing and Process Development. - Participate with executive leadership to proactively identify potential regulatory CMC risks to the organization, make adequate recommendations for mitigating risks and collaborate with other senior leaders in Manufacturing, MSAT and Process Development to implement selected and agreed upon strategies across all areas of the organization. - Assure sustainable, harmonized regulatory compliance for Humacyte manufacturing sites and contracted manufacturing operations (as applicable) through expert level insight, evaluation and support. - Identify and implement regulatory requirements for Design and Development, Technology Transfer, and Manufacturing/Bioprocessing. - Collaborate with Quality on Regulatory communications associated with U.S. and international regulatory inspections, including Pre-Approval Inspections. - Serve as the main point of contact with Development, MSAT, Manufacturing, Quality Assurance, Validation, and Quality Control regarding CMC regulatory compliance and reporting requirements. - Represent Humacyte for CMC discussions at meetings with regulatory authorities, including U.S. FDA and other competent authorities. - Prepare, review, and approve correspondences, submissions, protocols, and reports in support of regulatory filings (IND, IMPD, BLA, MAA, etc.). - Maintain consistent application of ICH Q9 Quality Risk Management principles in product development and lifecycle operations. - Manage and maintain policies, processes, and procedures associated with Humacyte’s Tissue Processing operations (internal or contracted) per 21 CFR Part 1271 and international regulations related to Human Cells, Tissues, and Tissue-Based Products. - Demonstrate and apply thorough understanding of U.S. FDA, EU, and Rest of World (ROW) regulations with respect to aseptic processing, biologics manufacturing, market authorization, and human cell and tissue-based products, including but not limited to: 21 CFR Parts 11, 210, 211, 600, 820, 1271; and relevant European Directives (EudraLex Volume 4, 2001/83/EC, 2004/23/EC). Qualifications - Minimum 8 years in a director-level and above role in Regulatory CMC or related function in a Biotechnology-related field. - Demonstrated experience in collaborating with the Quality department to prepare for and execute regulatory inspections including preparation, representation, and closing out of observations. - Proven record of CMC writing, reviewing, and approving regulatory submissions on topics of biological and cell therapy CMC processes and compliance, including pre-clinical stage, clinical stage, commercial-stage products and product candidates. - Demonstrated experience in developing, communicating, and implementing regulatory and compliance strategies to assure success in design, development, and commercialization processes for biologic products and medical devices. - Demonstrated knowledge of and expertise in product life cycle management, consistent with ICH and other international consensus guidelines. - Demonstrated success with planning, executing, and closing international regulatory inspections, with a focus on European regulatory submissions. - Possess a positive roll-up-the-sleeves attitude and optimistic outlook. - Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams. - Excellent organizational and time management skills with a keen ability to set own priorities in a timely manner. - High degree of flexibility and adaptability. - Self-motivated and critical thinker with outstanding interpersonal and business communication skills. - Represents the organization in a positive and highly professional manner. Requirements - Minimum BS degree in a biologics-related discipline, with education focus in biology, chemistry, biochemistry, microbiology, cell biology, or biotechnology required. Benefits - Competitive base compensation and bonus. - Stock Options. - 401k Plan with 4% Match and no Vesting Schedule. - Medical, Vision and Dental Plans. - Company Paid Long Term/Short Term Disability. - Company Paid Life Insurance. - Assortment of other voluntary benefits, including pet insurance; hospital indemnity; accident & critical illness plans; voluntary life insurance; legal protection plans and more. - 23 Days Paid Time Off (PTO) to start. - 10 Company Designated Holidays + 2 Floating Holidays. - Paid Parental Leave Policies.

• 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.