Samantha Hoopes, Phd, Rac Us Email & Phone Number

Somerville, Ma , Us

San Diego, Ca, Us

LEADERSHIP■ Head of global company regulatory affairs ■ Develops and implements the regulatory strategy for all company programs both US and ex-US ■ Acts as a point of contact for US and ex-US regulatory submissions ■ Supervises and provides mentoring to members of the regulatory affairs group■ Provides regulatory training, support, and advice to cross-functional team members PROJECT MANAGEMENT■ Manages regulatory submissions to health authorities, including tracking, document development, and publishing for company programs■ Responsible for managing the company's regulatory affairs and regulatory operations activities for all early and late stage development programs both US and ex-US, including managing vendors and consultants, timelines, SOWs, and budgetsREGULATORY AND MEDICAL WRITING■ Reviewing and authoring IND and market application submission documents, including nonclinical, CMC, and clinical, special requests, and briefing packages■ Provides strategic review of nonclinical and CMC documents and clinical protocols and reports

Durham, North Carolina, Us

LEADERSHIP■ Provided strategic input on the development and implementation of the regulatory strategy for all company programs for both short- and long-term goals ■ Developed and implemented regulatory SOPs ■ Acted as a point of contact for US regulatory submissions■ Monitored company regulatory compliance with SOPs, study protocols, industry standards, and regulatory requirements■ Provided mentoring and support to cross-functional team members on program-specific regulatory topics and requirements ■ Initiated a cross-functional training series to facilitate understanding of integrated product development across the companyPROJECT MANAGEMENT■ Managed regulatory submissions to health authorities, including tracking, document development, and publishing for company programs■ Responsible for managing the company regulatory operations activities for all development programs, including managing vendors and consultants, timelines, SOWs, and budgets■ Implemented a filing system for tracking regulatory submissions and interactions ■ Assisted QA and other staff with regulatory agency inspection and audit activitiesREGULATORY AND MEDICAL WRITING■ Reviewed and authored IND submission documents, including nonclinical, CMC, and clinical documents, special requests, and briefing packages■ Provided strategic review of nonclinical, CMC, and clinical documents, protocols and reports

Canton, Mi, Us

LEADERSHIP■ Provided strategic regulatory input and technical guidance on regulatory requirements to project teams including oversight of the development and publishing of regulatory submissions according to ICH guidance and monitored the impact of changing regulations on submission strategies ■ Oversaw the development and completeness of project deliverables by conducting expert reviews during development and prior to release to client■ Mentored medical/regulatory authors on development of regulatory documents, including label documents. ■ Worked closely with the Global Regulatory Operations department to lead departmental initiatives to improve overall efficiency, quality, and/or outputPROJECT MANAGEMENT■ Managed internal and external teams, as well as vendors, through short-and long-term global regulatory activities that supported the success of investigational products throughout their lifecycle, including the compilation, preparation, coordination, review, and submission to Health Authorities■ Assessed and managed project risks ■ Provided oversight into the creation of project plans, and input for timelines and agendas for both internal and external meetings■ Represented Regulatory Operations as the primary contact on global regulatory aspects of the project, providing regulatory guidance/ strategy/ perspective/ considerations in team meetingsBUSINESS DEVELOPMENT■ Supported business development to secure regulatory contracts by attending and leading regulatory capabilities presentations with potential US and ex-US clientsREGULATORY WRITING■ Reviewed and authored regulatory documents including expedited approval applications, orphan drug designations, meeting requests, and briefing documents for US and ex-US submissions■ Provided oversight during development of electronic common technical document compliant regulatory documents for early and late stage submissions■ Provided regulatory strategy support in development of target product profiles

Durham, North Carolina, Us

PROJECT MANAGEMENT■ Supported management and/or deliverable development for 16 regulatory submission programs.■ Helped lead 3 clinical studies from execution to completion.■ Supported regulatory projects and clinical studies ranging from 6 months to 2 years.BUSINESS DEVELOPMENT■ Maximized business opportunities for federal/commercial projects by securing contracts with comprehensive proposals.■ Reduced costs and improved efficiency by implementing programmed production of tables and documents for use by authors.■ Increased customer loyalty and repeat business by providing high-quality consulting and client support with candid interactions and advice on cost-saving options.LEADERSHIP■ Provided technical and regulatory input for the development of clinical study designs and product development plans.■ Mentored junior colleagues on standard operating procedures (SOPs), protocols, and relevant industry information.■ Maintain current working knowledge of good clinical practices (GCPs), International Conference on Harmonization (ICH) guidelines, and other requirements for regulatory authorities.■ Assisted with clinical and project management training for 200+ people advising and directing on the interpretation and implementation of regulations, guidelines, company procedures, and working practices.MEDICAL & REGULATORY WRITING■ Authored and contributed to the development of documents supporting regulatory submissions for drugs, biologics, devices, and combination products (e.g., CTAs, US INDs, 505[b][1] and 505[b][2] NDAs, sNDAs, BLAs, MAAs, IDEs510[k]s, PMAs).■ Authored and contributed to development of various regulatory and clinical documents (e.g. protocols, clinical study reports, investigator’s brochures, integrated product development plans, package inserts, gap analyses, informed consent and assent forms, study operations/regulatory manuals, briefing packages, CTD modules, and other documents to support regulatory submissions.

Durham, North Carolina, Us

PROJECT MANAGEMENT■ Researched current literature to assist in the design of clinical studies.■ Interacted with sponsors to determine the format, design, and direction of clinical/statistical reports.■ Assisted with clinical feasibility efforts (e.g., site survey development and implementation, enrollment projection calculations, and timeline considerations, etc.)■ Interacted with product sponsor and designated authors to determine content and direction of scientific publications.■ Coordinated poster and manuscript development with input from physicians, biostatisticians, pharmacologists, and regulatory personnel.■ Obtained author, sponsor, and internal approval of the final versions of abstracts, posters, and manuscripts.MEDICAL & SCIENTIFIC WRITING■ Led document review for regulatory submissions, monitoring timelines, and availability of expert and quality control reviewers.■ Contributed to investigational drug brochures; summarized animal and clinical studies drawing conclusions on potential safety.■ Summarized large collections of data from clinical, nonclinical, and chemistry, manufacturing, and controls (CMC) studies into succinct summaries for submission to regulatory authorities.■ Assisted with writing and editing documents for regulatory submissions (i.e., clinical trial authorizations [INDs, CTAs], marketing authorization applications [NDAs, BLAs, MAAs], and medical device authorizations [IDEs, 510Ks, PMAs]).■ Ensured compliance with the SOPs for publication development and edited manuscripts according to journal or style guidelines.

Research Triangle Park, Nc, Us

■ Completed multiple research projects on the role of arachidonic acid-derived eicosanoids in atherosclerosis using transgenic mouse models.■ Characterized a mouse model that was genetically deficient for a gene encoding a novel epoxide hydrolase, EPHX3.■ Studied the role of Cytochrome P450 4F2-derived 20-HETE in the cardiovascular system using a transgenic mouse model.■ Studied the angiogenic properties affected by the loss of soluble epoxide hydrolase in endothelial cells using both in vitro cell culture techniques as well as a genetic mouse model.■ Maintained multiple cell and animal model-based research projects and collaborated with internal and external investigators. ■ Mentored undergraduates in the laboratory to develop their scientific research skills.■ Edited manuscripts and reviewed journal articles.

Research Triangle Park, Nc, Us

Chair: 2015-2016; Branch Representative: 2013-2015■ Served as a liaison to NIEHS administration, managing issues about the trainees.■ Oversaw, organized and hosted monthly meetings with Steering Committee.■ Prepared and distributed monthly meeting agendas.■ Maintained and recruited new members for Steering Committee various subcommittees at NIEHS and NIH. ■ Led General Assembly meetings with all of the trainees twice a year to learn about career development opportunities offered to trainees at the institute.

Chapel Hill, Nc, Us

■ Gained knowledge on technology development, management, commercialization, and transfer as well as start-up companies ■ Developed skills to assist with projects in the UNC Office of Technology Development Supervisor: Henry Nowak, JD, MBA, MS

Chapel Hill, Nc, Us

■ Assisted in teaching an undergraduate Cell and Developmental Biology class.

Bagsvaerd, Dk

■ Performed DNA extractions and PCR reactions for an ongoing research project for the company

Salem, Va, Us

■ Worked on multiple research projects in biology, chemistry, and biochemistry laboratories

Doctor Of Philosophy (Phd), Cell And Molecular Physiology

Bachelor Of Science (Bs), Biochemistry