Regulatory Affairs for Pharmaceutical, Biotech and Medical Devices

DAVID R. DILLS

**** ***** ***, #*** • Lakeland, FL 33812 • Mobile 904-***-****

*******@*********.***

My name is David Dills, a seasoned Global Regulatory Affairs, Regulatory Strategist and Compliance professional with demonstrated capabilities and a track record with more than 35 years of accrued experience in the functional areas of Regulatory Affairs, Regulatory Intelligence, Regulatory Compliance, Global Regulatory PM and Strategist, and QA/QMS for US and international developers/manufacturers/sponsors for early-stage, mid- and large-size enterprises, including consultancies and CROs, for pharma, biologics, biosimilars, combos, POC, CDx, and medical device products, from investigational phase to marketing authorization and approval. I am open to evaluating new opportunities, and long- term strategic partnerships with companies that value innovation, the entrepreneurial spirit, and strategic thinking and support their regulatory, compliance, development, business, and commercial activities from end-to-end. Demonstrated leadership skills, business acumen, and ability to manage multiple complex and multi-disciplinary projects with competing priorities having a direct impact on site operations, pre-clinical/clinical trials, regulatory approvals, and commercial opportunities. Initiative-taking and solutions-oriented professional with broad US and global regulatory affairs and compliance and firsthand experience providing guidance and expertise in strategic interpretation of Health Authority and Regulatory Agency regulations, applicable laws, guidelines, legislative precedents, and directives to develop regulatory strategies and sound regulatory submissions based on breadth and depth of regulatory leadership experience with a broad spectrum of indications, product modalities and serving as US Agent/FDA Representative. Key focus is regulatory strategy and bringing products from new product development from pre-clinical to global market transfer and commercial release and collaborating with the regulatory authorities and agencies including, but not limited, to the FDA, EMA, MHRA, Health Canada, TGA, PMDA, MOH, CDSCO, ANVISA, NMPA and other HAs/CAs, and interfacing with the IRBs, including CROs, CMOs, KOLs, NBs, and other relevant partners while serving as the global point of contact for Regulatory Agencies in an efficient and expeditious manner. This is to ensure that regulatory provides consistent strategic messaging and cohesion throughout the entire regulatory and compliance lifecycle for the key stakeholders of the organization while fostering a culture of regulatory awareness within the organization. With my depth and breadth of regulatory and compliance experience, I examine all aspects of regulatory and compliance, to help companies uncover potential strategic regulatory risks while cultivating novel, targeted strategies to help companies achieve regulatory approval in multiple markets. This is accomplished by staying current with regulatory intelligence, the latest legislation, regulations, requirements, proposed guidance, and industry initiatives and making sure that companies are informed of changes in the regulatory environment that may impact their regulatory and business strategies, including authoring and approving RTQs, correspondence for HA commitments, and leading compliance remediation efforts for regulatory inspections.

• Regulatory advisor, regulatory strategist, regulatory lead, and/or project or program leader for multiple sponsor engagements within Orthopedics, Urology, Neurology, Immunology, Cardiology, Respiratory, Oncology (multiple indications), Hematology, ENT, Ophthalmology, Infectious Diseases/Vaccines, Radiology, Women’s Health, Dental, Dermatology, AI/ML-based SaMD using adaptive algorithms and Digital Health/SW devices, CDx, including Orphan Drugs (ODD) for Rare Diseases and specific for FDA/OOPD and EMA/COMP while providing strategic and proven regulatory leadership.

• Lead, manage, prepare, review, remediate, support, approve and spearhead regulatory submissions and lifecycle management with precision, including 510(k), PMA, IDE, IND, NDA and [505(b)(1) and 505(b)(2)] pathways, BLA, CTA, MAA, De Novo, 513(g) Requests, Orphan Drug Designation, special designations, variations, amendments, and supplements.

• Global Regulatory and regulatory strategist with collaborative cross-functional teams in all stages of development and CT phases, including interfacing with C-Suite Management, R&D, ClinOps, QA, Mfg., PRC/Ad/Promo, Monitoring, Medical Affairs, OPS, CMC, Compliance, Global RA teams, Safety/PV, Biometrics/DM, QM, BD, Commercial, Legal, Distribution/Supply, and support integrated development plans, and other workstreams to drive development of companies’ assets and platform technologies.

• Lead, manage and support pre-submission meetings, including Type B, EOP2, C, D, Q-SUB, SIM, briefing documents, negotiations, for FDA meetings and lead interactions with Health Authorities in formal meeting settings, including providing pre-meeting coaching. Support Request for Scientific Advice and Protocol Assistance with EMA, and interfacing with other HAs and providing post-filing support for requests and inquiries. Contribute to building a strong and trusted relationship with the global Health Authorities while providing strategic regulatory guidance to cross-functional project teams, supporting product development and post marketing commitments, and conducting training on topical topics to educate teams on regulatory requirements and compliance strategies.

• Develop regulatory roadmaps, regulatory submission trackers, KPIs, metrics, including supporting clinical development plans for key development inflection points based on company’s needs, identify regulatory risks and mitigation strategies, and advising regulatory operations and project teams on defined regulatory strategies for development programs and commercial activities with global regulatory strategy for long-term planning.

• Develop and implement regulatory submission content plans, registration strategy plans (RSP) and ensure cross- functional alignment with overall development plans. Develop and execute, or oversee global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs and implementation of pre-clinical regulatory strategies for projects in all stages of development.

• Lead a portfolio of consultancy projects to ensure effective delivery of robust client solutions. Collaborate with clients to define requirements, scope projects, prepare business case and statement of work. Add gravitas and subject matter expertise to the analysis, design, and implementation of projects. This includes owning and building client relationships to generate revenue and drive business growth with ongoing selling and marketing of services to contribute to revenue and sales growth for consultancies and CROs. A key aspect of this is to conduct new business development activities, support lead generation and business defense meetings, and develop client focused, needs based proposals.

Industry Presentations/Regulatory Newsletters/White Papers US Agent/FDA Representative Support NPI/R&D, Design/Dev/Labeling/Advertising/Promotion/PRC Teams KPIs/RTQ Responses/Commitments PMO/PMS/210-211/600-610/820/ICH/GCP/IEC/ISO 13485/14971/14155 Registrations/PADER/PSUR/IP Review Regulatory Strategy/Intel/Surveillance, RIM Tools/Veeva and Other RIMs IMPD/DSUR/CMC Gap Assessments GxP Audits/HA-Regulatory Readiness Inspections and Regulatory Audits MDR, IVDR, CE Mark CTA/CTR-CTIS, REMS, PIP, SW/Cybersecurity/AI-ML/SaMD/Digital Health Import/Export of IMPs/DPs 505(b)1/2, Emergency Use Authorization, Priority Review Support BD/Bid Defense Mtgs Fast Track, Breakthrough Therapy, BTD, PRIME Regulatory Submission Content Planning Regulatory Operations/PM/Global Regulatory Steering Committee Regulatory Presentations – Investors Pitch Deck Preparatory Support and Coaching for FDA/HA/Divisional Meetings Regulatory Due Diligence and Assessments PROFESSIONAL EXPERIENCE

May 30, 2024 – Current

Global Regulatory Affairs Consultant and Regulatory Strategist (freelancer/remote)

Lakeland, FL (previously Jacksonville, FL)

• Manage regulatory projects with multiple competing priorities having a direct impact on site operations, regulatory filings, approvals, and commercial opportunities, utilize regulatory intelligence, and serve as US Agent/FDA Rep

• Develop and execute comprehensive regulatory strategies for Sponsors, considering their specific business objectives and regulatory requirements and commercial considerations in global markets, and support sound regulatory submissions, interactions, and outcomes with regulatory authorities, and provide coaching/mentoring to RA teams

• Develop and lead regulatory strategies and plans for the development, registration, and life-cycle management of drug and device programs, and global regulatory development/registration strategy plans (RSP) with regulatory intelligence

• Function as the primary liaison with global regulatory agencies to expedite approvals and resolve key regulatory issues

• Lead and support regulatory due diligence and assessment activities for registrations, licensing, and renewal reviews

• Support for regulatory compliance for independent reviews of labeling claims, TPP, advertising and promotional materials 2

• Collaborate with the cross-functional teams and provide regulatory submissions and pre-and-postmarket project leadership and guidance to navigate the landscape for MDR and IVDR compliance including CDx, POC and digital health products

• Support, coordinate, manage, and/or review and remediate Health Authority meeting documents, special designation requests, regulatory applications including IND, IDE, CTA, 510(k), PMA, De Novo, NDA, BLA, MAA, ODD, and consideration for [505(b)(1) and 505(b)(2)] pathways, AI/ML SaMD application and post-filing support, including variations, amendments and supplements

• Lead the interactions with Health Authorities in formal meeting settings, including providing pre-meeting coaching and preparation of briefing documents for pre-sub meetings for FDA, EMA and other HAs, and manage complex intelligence query requests, author/approve RTQs, and provide regulatory intelligence in support of a range of operational planning activities

• Provide consultative support at all phases while providing support from initial regulatory strategy development, proof of concept, feasibility, support for clinical study design, to pre-clinical/clinical FIH to product commercialization for marketing authorization

• Develop and execute regulatory compliance strategies for DSCSA compliance, procedural assessments, training, and importation and exportation consultation for controlled substances, investigational and approved medicinal products

• Monitor changes in the regulatory environment and provide regular updates to clients and internal teams on emerging regulations, guidelines, industry best practices, lead and support regulatory and compliance inspectional readiness

• Coach and manage project teams to encourage teamwork and support development

• Collaborate with cross-functional teams, i.e., C-Suite management, R&D, Compliance, DM, Safety, Medical Affairs, Monitoring, QA, GRO, Supply, Commercial, ClinOps, and Legal, to ensure regulatory requirements are integrated into business processes

• Take a streamlined approach and prioritize precision in regulatory and compliance, optimizing every facet from strategy development to operational execution and developing, implementing, and advising on global regulatory strategies

• Conduct training sessions and workshops to educate clients and internal teams on regulatory requirements, processes, and compliance strategies, including developing RA metrics, KPIs, dashboards and other compliance/RA tools

• Provided expert advice to internal teams and subsidiaries on regulatory issues as they arise with the developmental compounds, including investigational devices or marketed products throughout the entire life cycle

• Monitor and review the technical and commercial progress of regulatory projects ensuring compliance with project plans, deadlines, and budgets

July 2018 – May 30, 2024

Director of Regulatory Services (remote – position eliminated due to redundancy and post-acquisition) ClinChoice (a CROMSOURCE Company), Full-Service CRO Verona, Italy - Cary, NC - Ft. Washington, PA (HQ)

• Provided regulatory strategic leadership, and led health authority interactions and for FDA, HC, EMA, and other CA/Regulatory Agency meetings and for sound regulatory submissions from pre-clinical to marketing authorization approval and assessments for proposed target product profile, regulatory strategy plans (RSP), and registration plans (RP) for multiple indications and modalities

• Managed regulatory projects with multiple competing priorities having a direct impact on site operations, regulatory filings, approvals, and commercial opportunities, served as US Agent/FDA Rep, and member of Executive Steering Committee

• Led the interactions with Health Authorities on behalf of companies in formal meeting settings, including providing pre- meeting coaching and preparation of briefing documents, negotiations and post-filing support for FDA, EMA and other CAs

• Provided guidance and support to Sponsors during interactions with all regulatory authorities, including inspections, audits, and product registrations; coordinated the preparation, submission, and post-filing support with WW Regulatory Agencies

• Supported collaborative efforts with cross-functional teams while managing Regulatory Intelligence/oversight for Regional Regulatory Reps and provided coaching/mentoring/training and developing regulatory staff, including Sr. Regulatory Intelligence and Regulatory Manager, and conducted Ad/Prom reviews, and internal and external regulatory training and workshops

• Led and managed regulatory strategy development and submission management lifecycle for regulatory filings

• Provided expertise in strategic interpretation of Health Authority regulations, guidance, and directives to develop regulatory strategies and sound regulatory submissions based on breadth and depth of regulatory leadership experience with multiple indications/product modalities for pharma, biologics, combos, CDx, POC and wearables

• Coordinated, managed, authored, and/or reviewed Health Authority/Agency meeting documents, special designation requests, Amendments, Supplements, CTA, IND, IDE, NDA, MAA, ODD, Digital Health-AI/ML SaMD clinical guidance, post-filing support and responses, including CA/Notified Bodies for CEP/CER, MDR, CE Mark, IVDR, Regulatory presentations support for Investors Pitch Deck for start-ups, and managed and resolved complex RI queries 3

• Synthesized information from global requirements databases as well as interaction with local country experts as needed and provided regulatory intelligence in support of a range of operational study design and operational planning activities, including regular updates on new information that could impact clinical trial execution as well as ad hoc requests to input into feasibility

• Shared/input data into systems or tools to enable effective knowledge management of country level operational intelligence data, and conducted regulatory due diligence/compliance assessment activities for registrations, licensing, and author/approve RTQs

• Developed and executed regulatory compliance strategies for DSCSA (Track & Trace) compliance with consultative guidance for system evaluations, procedure assessments and importation/exportation inquiries of medicinal/CS products

• Stayed abreast of evolving regulatory trends, guidelines, and requirements to provide up-to-date and accurate regulatory advice to clients, developed global regulatory KPIs, metrics and dashboards to support CQI and inspectional readiness initiatives

• Collaborate with clients to identify potential regulatory risks, assess their impact, and develop mitigation strategies

• Conducted Quarterly Regulatory Governance Meetings for and stakeholder of the Executive Steering Committee

• Defined new strategies for additional business growth of the Regulatory Services Department (RSDT) and defined new service offerings adapted to the market evolution and customer’s demand

• Participated in business lead generation as requested by the Client Project Development Division (CPDDIV) personnel and working directly with CEO/COO/Sr. Mgmt., managed the regulatory team, and provided mentorship and guidance

• Supported CPDDIV and BD in the processing of requests for RFIs, RFPs, and budgets for ensuring correct operational input and supported bid defense meetings

• Participated in external regulatory training, conducted internal/external presentations, current with professional publications, maintained industry networks, working with KOL’s, and to keep knowledge and stakeholder concerning regulatory affairs up to date; deep familiarity with current regulatory guidance, codified regulations, GxPs, legislation, and industry trends

• Collaborated with cross-functional teams, such as C-suite management, compliance, QA, medical affairs, clinical affairs/ClinOps, corporate marketing, safety, commercial, and legal, to ensure regulatory requirements are integrated into business processes

• Developed worldwide product regulatory strategy to obtain shortest time to approval by regulatory agencies for multiple indications and supported CMC gap assessments and remediation efforts

• Represented Regulatory Services in cross-functional team meetings; supported and managed Regulatory Intelligence/Operations, Regulatory Database and Regulatory Library; and lead health authority interactions, regulatory submissions, and other activities

• Monitored and reviewed the technical and commercial progress of regulatory projects ensuring compliance with project plans, deadlines, and budgets

April 2016 – July 2018

Senior Principal, Regulatory Affairs & Compliance Consultant, Interim President (remote) NovaQual, LLC

Logan, UT

• Developed comprehensive regulatory strategies considering specific business objectives and regulatory requirements while provided evolving regulatory trends and requirements to provide up-to-date regulatory advice/guidance and strategic regulatory development and regulatory plans for digital health, CDx, novel drugs/devices, and IVDs

• Provided guidance and support to companies during interactions with all regulatory authorities, including inspections, audits, and product registrations, and support for sound submissions, including IND, NDA, IDE, 510(k), PMA, De Novo, and 513(g) request

• Lead and supported regulatory due diligence and regulatory assessments for registrations, and coached/mentored RA Teams

• Managed HA RTQs/AIs, HA Commitments, review of labeling claims and regulatory reviews for advertising and promotional materials

• Collaborated with companies on strategies to identify potential regulatory risks, assessed their impact, and developed mitigation strategies and conducted due diligence and regulatory assessments for TPP, claims for different TAs and product modalities

• Regulatory Agency liaison and supported submission management oversight and regulatory PM/PD activities Provided support for NPI, strategic regulatory guidance, regulatory strategy to cross-functional teams for product development and postmarketing commitments for multiple pharma, biotech, device, and combination product modalities from strategy, feasibility to commercialization, including CMC assessments and proposed corrective action/remediation

• Developed regulatory roadmaps, application and submission trackers, and use of regulatory intelligence tools for query requests

• Regulatory Liaison, US Agent, and established regulatory strategy and plans to support product development through commercialization, lead all health authority interactions and preparatory support for meetings, regulatory presentations, and support for investors pitch deck for start-ups, and managed complex intelligence query requests from stakeholders

• Deep familiarity and knowledge with current regulatory guidance, applicable laws, GxPs, legislation, and industry trends

• Supported BD/senior management in the processing of requests for RFIs, RFPs, and budgets for ensuring correct operational input

4

• Conducted training sessions and workshops to educate clients and internal teams on regulatory requirements, processes, and compliance strategies

• Monitored and reviewed the technical and commercial progress of regulatory projects ensuring compliance with project plans, deadlines, and budgets, including supporting regulatory compliance KPIs, metrics and dashboards

• Coached and managed project teams to encourage teamwork and supported development

• Mentored and trained project team members and colleagues

• Defined new strategies for additional business growth and defined new service offerings January 2016 – April 2016

Global Regulatory Affairs & Compliance Consultant (remote and contracted by multiple companies) Jacksonville, FL

• Collaborated with cross-functional teams, developed registration strategy plans (RSP), submission trackers and supported CDP to ensure cross-functional alignment with overall development plans and coaching for pre-sub meetings

• Supported PM activities for submissions from initial strategy development to submission lifecycle management

• Provided guidance and support to sponsors during interactions with all regulatory authorities, including inspections, audits, and product registrations, including assessment and review of indications, TPP and the potential pathway to regulatory approval

• Supported regulatory due diligence/assessment activities, and managed complex regulatory intelligence query requests

• Supported reviews of labeling claims and for advertising/promotional materials for compliance, and coached RA/Project Teams

• Provided strategic interpretation of Health Authority regulations, guidance, and directives to develop regulatory strategies and sound regulatory submissions for IND, NDA, Traditional/Special 510(k), De Novo and post-filing support

• Provided regulatory submissions and post-market project leadership and guidance to the stakeholders, including HA RFI/RTQs

• Led regulatory oversight and governance with RA, R&D/Software Design & Development, and ClinOps Teams

• Monitored and reviewed the technical and commercial progress of regulatory projects ensuring compliance with project plans, deadlines, and budgets

August 2015 – January 2016

Senior Regulatory Affairs & Compliance Consultant (remote) NovusLife

Waltham, MA

• Provided regulatory consultative services and overseeing development of compliant, high quality regulatory submissions to support early development, registration, and life cycle management and collaborated with project teams on submission preparation timelines, processes, and requirements, including labeling, ad/prom reviews, and CMC assessments

• Provided guidance and support to clients during interactions with all regulatory authorities, including FDA GxP inspections, audits, and product registrations for multiple indications and product modalities for devices, diagnostics, and pharma

• Supported regulatory assessments and due diligence activities for registrations, licensing, and renewal reviews

• Supported reviews of draft labeling claims, advertising and promotional materials for US and EU compliance

• Provided support from initial regulatory strategy development, feasibility, preclinical, clinical to commercialization, assessing TPP, and spearheaded IND, MAA, NDA, CTA, 510(k), IDE, and ODD subs

• Developed regulatory and compliance roadmaps and application and submission trackers to key development inflection points based on client’s needs while identifying regulatory risks and mitigation strategies, supported operational activities, and managed HA RTQs, and regulatory intelligence queries

• Deep familiarity and knowledge with current regulatory guidance, codified regulations, GxPs, legislation, and industry trends

• Regulatory lead in client cross-functional teams in all stages of development, regulatory gap assessments, integrated development plans, and other workstreams to drive development of clients' assets and platform technologies forward

• Regulatory strategy development, regulatory planning, registration plans with regulatory intelligence, and preparatory support for Agency meetings with EMA/CDRH/CDER/CBER, briefing documents and coaching with teams/clients

• Monitored changes in the regulatory environment and provide regular updates to clients and internal teams on emerging regulations, guidelines, and industry best practices, including RA KPIs, metrics, and regulatory compliance dashboards

• Conducted training sessions and workshops to educate clients and internal teams on regulatory requirements, processes, and compliance strategies, including RC/Global RA metrics, dashboards, and trackers for OFI/CQI initiatives

• Defined new strategies for additional business growth of the company and defined new service offerings

• Supported CEO and senior management in growing the business and portfolio of services, including the processing of requests for RFIs, RFPs, and budgets for ensuring correct operational input and supported BDMs and collaborating directly with clients and Sponsors

5

May 2012 – August 2015

Global Regulatory Affairs Consultant (remote and contracted by multiple service providers/CROs) Jacksonville, FL

• Provided regulatory and compliance support for CRO, submission management lifecycle and interactions with FDA and EMA

• Provided support for establishing and executing regulatory strategies, clinical trial support, regulatory planning, defining product classifications, including product registration plans, and managed regulatory intelligence query requests

• Led and supported regulatory due diligence activities for registrations and licensing requirements if requested

• Supported and reviewed labeling and regulatory compliance reviews for advertising and promotional materials

• Deep knowledge with current regulatory guidance, regulations, GxPs, legislation, and industry trends

• Provided submissions and post-market project leadership for multiple indications and product modalities

• Supported efforts involving HA commitments, RTQs, enforcement, compliance events and remediation and conducted clinical/GxP audits, CMC assessments, and preparatory support for HA/CA inspections

• Subcontracted by CRO’s and third parties to provide regulatory and compliance consultative services, support project teams, author specific sections and/or review Health Authority meeting documents, investigational and commercial regulatory submissions, and preparation and management of regulatory documents to support project scope and deliverables

• Provided support from initial regulatory strategy development, submission lifecycle management, and Agency correspondence, and managed complex regulatory intelligence query requests

• Monitored and reviewed the technical and commercial progress of regulatory projects ensuring compliance with project plans, deadlines, and budgets and collaborating directly with clients October 2011 – May 2012

Principal Consultant, Regulatory Affairs & Compliance (remote) Wipro Technologies

East Brunswick, NJ

• Consultative support for regulatory projects with multiple competing priorities having a direct impact on site operations, regulatory filings, approvals, and commercial opportunities based on regulatory strategies for programs in different phases of development, and managed complex regulatory intelligence query requests

• Provided guidance and support to companies during interactions with all regulatory authorities for pharma, IVDs and devices, including inspections, audits, and product registrations and assured compliance with relevant regulations and standards by conducting thorough reviews and assessments of client products, processes, and documentation

• Supported regulatory due diligence activities for registrations, renewals, and support for IND, IDE, NDA, CTA and 510(k)

• Supported reviews for labeling claims, IU, advertising, and promotional materials for compliance

• Provided Regulatory leadership experience from multiple indications and product modalities with regulatory compliance roadmap and generated site master plan and support for offshore operations with different disciplines for OEM and collaboration with partners and TPVs, and provided regulatory agency inspections readiness support

• Provided expertise in strategic interpretation of Health Authority regulations, guidance, and directives to develop regulatory strategies and compliance oversight, regulatory/project lead in client cross-functional, integrated development plans, and other workstreams, and assessments of regulatory filings and Health Authority interactions, RTQs, and commitments

• Represented and provided regulatory and compliance oversight and governance for NPI, meeting regulatory commitments and deadlines, conducted regulatory assessments and regulatory support for SW/SaMD devices

• Supported client project teams related to project activities, FDA requests and correspondence and mitigate and analyze the impact of any project risks while providing regulatory oversight, including CMC assessments and RA metrics for CQI

• Conducted training sessions and workshops to educate clients and internal teams on regulatory requirements, processes, and compliance strategies

• Supported management the processing of requests for RFIs, RFPs, and budgets for ensuring correct operational input and collaborating directly with clients

• Monitored and

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