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Global Project Management ~ Staff Leadership ~ Quality & Validation
Offer significant expertise in regulatory affairs, strategy development, quality control and assurance (QC/QA), due diligence, project management, and process improvements.
Advanced knowledge of FDA regulations and guidelines specific to pharmaceutical products.
Successful track record in regulatory leadership on cross-functional teams.
Structured, systematic, and highly skilled at driving unified efforts throughout all departments.
Well-developed analytical, troubleshooting, documentation, reporting, and organizational skills
Draw upon strong interpersonal skills to train, direct, supervise, motivate and empower cross-functional personnel to achieve strict goals for regulatory compliance.
Genzyme Corporation Cambridge, Massachusetts, 2008 to Present
Senior Manager / Associate Director, Global MS Publications (2015 to Present)
Mastermind strategic development of medical, clinical and scientific data dissemination efforts in close cooperation with cross-functional teams and internal stakeholders spanning multiple regions and countries.
Play an integral role in planning and execution of global scientific communication points and global publication strategic and tactical plans, as well as global medical congresses.
Align, mobilize, engage, and encourage collaborating co-authors and internal resources toward crafting successful publications.
Govern development of annual global publications plan, and facilitate updates to publications-related internal guidance and resource documents.
Effectively navigate compilation of high-quality abstracts, posters, slide decks and manuscripts.
Employ strong project management expertise to coordinate vendors and external/internal resources encompassing Genzyme contributors, meeting planners and Medical agency in development of tactics and event planning.
Join forces with internal statistical resources to devise, tweak, and perfect analytical plans to meet publications strategic objectives.
Perform forecasting and manage associated budgets for publications development and data distribution.
Identify and solicit external neurologists and MS experts as authors for publications and abstracts.
Manager, Regulatory Affairs (2010 to 2015)
Promoted to serve as global regulatory lead for two anti-CD52 monoclonal antibodies, proficiently steering compliant development, registration, and complete lifecycle management efforts.
Directed and executed submission of major US (sBLA, IND), EU (MAA, IMPD), and other global applications and dossiers by driving cooperative efforts among global regulatory affairs and internal staff.
Led development of strategy and materials to prepare for FDA negotiations; prepare teams for negotiation meetings; and coordinate and interact directly with FDA.
Designed presentation materials for FDA advisory committee and determine core presentation strategy and perform in-meeting slide triage for efficacy, study design, clinical pharmacology, and non-clinical disciplines.
Independently handled preparations for pre-submission meetings, coordinated meeting logistics, reviewed and approved labeling and responses to healthy authority questions.
Directed strategic planning activities and lead submissions for international marketing application plans.
Communicated well defined regulatory strategies across platforms and provided regulatory direction to global development project teams and clinical study teams.
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Guided development of non-clinical, clinical, and technical documentation such as clinical study reports, protocols, company core data sheets, labeling, investigator brochures, and financial disclosure for all types of communications and submissions.
Oversaw post-approval commitment and medical affairs study protocols and scientific communications including conference and training materials and medical science liaison materials.
Senior Regulatory Affairs Associate (2008 to 2010)
Promoted to serve as global regulatory lead for medical device/drug combination product designed to treat osteoarthritis of the knee.
Directed staff in preparing and submitting clinical trial application documents, marketing applications, supplements, design dossiers, amendments, annual reports, responses to questions, and product labeling.
Compiled document packages for regulatory submissions and seamlessly liaised with FDA.
Demonstrated outstanding skills in design control, risk analysis, CMC (Chemistry Manufacturing and Controls) change control assessments, authoring procedures, and devising product development plans.
Delivered presentations on regulatory activity status to steering committees and program meetings.
Amgen Inc. West Greenwich, RI, 2002 to 2008
Senior Associate, Regulatory Affairs (2007 to 2008)
Directed, supervised and monitored development of CMC Electronic Common Technical Document (eCTD) file for a major initial supplemental Biologic License Application (sBLA) and life cycle submissions.
Defined product submission timelines, collaboratively evaluated change controls, participated in content of documents for submissions, and reported on status to senior management.
Participated in design, modifications and enhancement of departmental training programs and materials.
Senior Associate, Regulatory Compliance (2005 to 2007)
Spearheaded preparation and management activities for regulatory inspections and internal audits.
As lead internal auditor, devised annual site audit schedule, delivered final audit reports to management, reviewed responses, and tracked audit commitments through to timely closure.
As war room general, managed set-up and implementation of all roles and administration including potential risks, mitigation strategies, and preparing staff through interviews, mock facility tours and training sessions.
Established and documented procedures for responses to site inspection and observations.
Functioned as lead compliance representative for Quality laboratories.
Authored subsections and coordinating revision of site master file for 2005 EMEA inspection.
Associate II, Quality Analytical Laboratories (2002 to 2005)
As Subject Matter Expert (SME) for Laboratory Information Management System (LIMS) project, created strategy, authored scripts, assembled LIMS templates, compiled business use cases and performed gap analyses; successfully earned high performance recognition upon project completion.
Delivered status reports to senior quality lab, validation, QA and manufacturing management
Initiated and maintained SOPs, provided related training to company personnel, and assigned lab tasks.
Managed extensive collection of laboratory samples for testing and conducted end user training.
Master of Science in Quality Assurance and Regulatory Affairs, Temple University, Philadelphia, PA, 2008
Bachelor of Science in Biology, The George Washington University, Washington, D.C., 2001
Regulatory Affairs Certification (RAC), 2011
Medical Devices CE Marking Certification, BSI, 2008
Lyophilization Principles and Practices, PharmaNet 2005
Regulatory Affairs Professional Society
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