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Click here or scroll down to respond to this candidateCandidate's Name , MSDDLead a world class regulatory team and collaborate with other experts to optimize product pathways to market from early concept through post marketing by monitoring and leveraging the latest regulatory insights.Director, Regulatory Affairs Street Address - PresentAltasciences, RemoteProvide direct management, strategic leadership and FDA liaison guidance and mentoring to Project Managers in US Regulatory Affairs, while at the same time leading US professionals towards integration with global development requirements. Accountable for assuring optimal content and focus for FDA submissions, meetings, SPAs and requests for CAC review and Regulatory Intelligence.Authoring and reviewing key regulatory documents, planning, implementing, and orchestrating regulatory operations, and leading team of four associates to complete RA deliverables.Develop regulatory strategy for various candidate products/drugs including combination, device, biologics, and small molecule for US market approval from nonclinical through planned phase 3 trials.Consulting on nonclinical development to enable IND, authoring immunogenicity assessments, protocols for Phase1/2/3 studies, IBs, risk assessments and REMS, and leading early Agency engagement (pre-IND meetings, INTERACT meetings, Type C meetings).Developed Regulatory Intelligence tools using AI, RegIntel newsletters, and trained associates.Principal and Founder 2022 - PresentSTEM Associates, LLC., Henrico, VA Responsibilities include making major business decisions and managing the overall operations and resources of STEM Associates, LLC. Regulatory consulting.Preparing clients to navigate a complex and dynamic regulatory environment by identifying opportunities and advising on regulatory science and stakeholder engagement strategy.Authoring and reviewing key regulatory documents (ITPs, INDs, 501(k)s, PMTAs, NDAs, BLAs, IBs, CSRs, IRAs, summaries, and TPPs).Acting as US agent for regulatory interactions and submissions.Sr. Director, Global Regulatory Affairs and Principal Consultant 2023 - 2023Dynarex Corp., Orangeburg, New YorkAs a member of the senior management team, responsible for overseeing the development and execution of global regulatory strategies to achieve the earliest possible approvals of all regulatory submissions, and within the context of analyzing global regulatory requirements and procedures, assure cost effectiveness and compliance. Required to lead in establishing creative, constructive interactions with regulatory agencies to ensure that all projects have clearly defined regulatory paths and milestones leading to successful filings and approvals.Improved communication and collaboration by establishing a Global Regulatory Affairs Council, Data Governance program, and Document Control Committee.Improved product development efficiency by implementing a comprehensive evaluation and qualification process and automation.Implemented Veeva RIM system, QMS, and promotional material review (PromoMats).Implemented issues management meetings that resulted in all stakeholders working from a comprehensive regulatory and quality strategy, and compliance.Successfully integrated two departments into one high performing organization.Regulatory Lead, Regulatory Affairs 2021 - 2023JUUL Labs, Inc., San Francisco, CA (Remote)Responsibilities leading regulatory affairs professionals and implementing Regulatory operations. Developed and implemented innovative regulatory strategies that provided business flexibility and met regulatory requirements for critical and timely submissions including strategy and review of modified risk labels for future and modified claims.Implemented a Veeva RIM and integrated with various companywide systems and processes (clinical, manufacturing).Reduced staff regulatory report preparation time by >40% via data controls and automation.Utilized automation to reduce regulatory evaluation time >70%.Helped develop scientific strategies that resulted in product PMTAs and MRTPAs.Worked closely with external affairs to engage with Health Authorities to develop policy.Built a Regulatory Intelligence database and analytics for impact to product development and post-marketing requirements and to support litigation or product defense.Developed novel smart device for aerosol delivery, worked to patent and submit for marketing approval.Sr. Specialist - Regulatory Science and Product Integration 2017 - 2021Altria Client Services Inc., Richmond, VAResponsibilities included assessment of regulatory and product risk, manufacturing feasibility, and Regulatory strategies for various smokeable and smokeless products, along with authoring and reviewing Regulatory submissions documents and enhancing Regulatory authoring and review processes to critically evaluate scientific information.Successfully completed 100s of toxicology, chemistry and manufacturing controls modules, and substantially equivalent FDA submissions.Medical/Regulatory writing for various regulatory submissions, deficiencies/IRs, external affairs, and scientific engagement.Assisted Sr. Scientists with data management process development and statistical methods.Utilized automation to create reports, integrating LIMs, manufacturing systems (SAP), and built RIMs (Veeva) to generate real time data in regulatory documents, compliant with FDA and EU data standards.Developed Regulatory strategies for novel products spanning various categories and markets.Developed and implemented quality control for regulatory submissions review.Led integration of acquired companies teams and products and identified integration synergies.Regulatory Specialist - Product Development 2016-2017Altria Client Services Inc., Richmond, VAResponsibilities included working with scientific and regulatory affairs professionals and manufacturing engineers to managing large amounts of product data and development decisions, create manufacturing processes, and implemented innovative regulatory tools to provide real time assessment of product performance and regulatory acceptance review.Worked with legal and developed patent strategies on processes and products.Developed sensory assays in sensory lab for assessment of novel products.Utilized automation to create reports, integrating LIMs, manufacturing and RIM to generate real time data in regulatory documents, compliant with FDA and EU data standards.Worked with Senior Scientists to review statistical methods for regulatory acceptance and data quality control automations.Reviewed product data and developed processes to reduce variance in final reports.Professional Medical Program Doctoral Student 2013-2016CARILION HOSPITALVirginia Tech and Radford School of Medicine, Roanoke, VALaboratory Manager and Graduate Researcher 2012-2013DEPT OF PHARMACOLOGY AND TOXICOLOGYVirginia Commonwealth University, Richmond, VAInvestigated the potential role of IL-6 in brain injury.Abuse liability research for multiple drugs in development portfolio, including development (preclinical studies) on glyx-13.Advanced training on aseptic surgical techniques, intravenous cannula surgeries, and osmotic pump implantation.Assisted in fluid-percussion induced traumatic brain injury procedures.Executed many experimental assays including self-administration, locomotor activity, place conditioning, warmwater tail-withdrawal, and visual discrimination tasks using non-human primates and rodents.Research grant: Assessing the antidepressant-like effects of ketamine in mice, used differential reinforcement of low rate 72 second schedule of ketamine in a mouse model.Performed many experimental assays, data collection, evaluation, and presentation. Scientific writing for publication and presenting research at international conferences.EducationMaster of Science Pharmaceutical Science, Drug Development, University of Cincinnati College of Pharmacy, Cincinnati, OHGraduate Certificate in Global Regulatory Affairs,Graduate Certificate in Clinical Trials2023Bachelor of Science Psychology, Biology Virginia Commonwealth University, Richmond, VA2013 |
