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As a Senior Regulatory Affairs Consultant, I excel at providing subject matter expertise to assist organizations in advancing pharmaceutical and medical device products through all stages of regulated development.My background as a seasoned life science professional encompasses 25+ years of progressive experience in the pharmaceutical, medical device, and animal health industries. This includes working within small, mid-sized, and large companies, startups, and multinational conglomerates.I am well versed in working remotely and collaborating with global teams throughout all phases of new product development from pre-clinical through product launch. With this experience under my belt, I am knowledgeable in both domestic and international regulatory requirements.- CORE COMPETENCIES -• Regulatory Strategy Development• Regulatory Requirements & Guidelines• Regulatory Affairs Agency Liaison• Pharmaceutical Industry• Clinical Trials / Clinical Study Design• Project Management• Regulatory Compliance & Reporting • eCTD, IND, NDA, IMPD, MAA, GCP, GLP, GMP• Regulatory Filings & Submissions"Be kind whenever possible. It is always possible." Dalai Lama
Glm Quality Research Consulting, Llc
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Founder And Principal ConsultantGlm Quality Research Consulting, Llc Jun 2011 - PresentLoveland, ColoradoAs Founder and Principal Consultant, I provide strategic counsel and new product development support on a contract-basis to corporate clients in the human pharmaceutical and animal health industries.
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Senior ConsultantNda Group Ab Feb 2021 - May 2023United StatesAs a Senior Consultant I contributed to the success of the business by providing high quality, efficient Regulatory consultancy services to assigned clients. -
Senior Global Regulatory Affairs ConsultantReven Pharmaceuticals Apr 2018 - Jun 2020Golden, Colorado, United StatesAs Sr Global Regulatory Affairs Consultant, I provided oversight and direction for executing on clinical and regulatory strategies. This required aligning regulatory strategy with company goals, reviewing protocols and data for regulatory submissions, and advising on FDA and ICH guidelines. -
Sr. Director, Regulatory And Clinical AffairsChd Bioscience, Inc. | Armis Biopharma, Inc. Apr 2015 - Aug 2017Fort Collins, Colorado AreaAs Senior Regulatory Consultant, I conceived and established regulatory development strategies. This included managing and mentoring product development and regulatory staff as well as providing counsel and subject matter expertise when interpreting FDA and ICH guidance documents.
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New Product Development ConsultantChd Bioscience, Inc. | Armis Biopharma, Inc. Aug 2013 - Mar 2015Fort Collins, Colorado AreaAs New Product Development Consultant, I split time between independent contractor and W-2 fulltime status while focusing on new product development. This included implementing project charters and plans as well as leading cross-functional project teams through product development processes.
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Clinical Affairs Manager, Pathogen Reduction Technology (Prt)Terumo Bct Jun 2011 - Jun 2013Lakewood, ColoradoAs Clinical Affairs Manager for Pathogen Reduction Technology (PRT), I defined clinical program strategies and collaborated with advisory boards to plan clinical programs. This included preparing clinical sections for regulatory documentation and negotiating clinical research contract agreements. -
Research ManagerColorado Quality Research, Inc. Jan 2011 - Jun 2011Wellington, ColoradoAs Research Manager, I provided leadership and subject matter expertise in the areas of GLP, GCP, and GMP regulations. This included preparing research study protocols as well as facilitating staff training to study site associates on protocols and technical conduct.
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Research And Development Project ManagerElanco Animal Health Sep 2004 - Aug 2010Greenfield, IndianaAs Research and Development Project Manager, I specialized in leveraging my research expertise in the food and companion animal health industries. This included authoring POC, GCP, and GLP study protocols and final reports as well as preparing regulatory submissions and managing research project budgets. -
Associate, Clinical Trial Material OperationsElanco Animal Health Nov 2002 - Sep 2004Greenfield, IndianaAs Associate, Clinical Trial Material Operations, I provided clinical and research materials for food animal and companion animal projects. This required collaborating with project managers and development team on strategy, inventory management, and proper distribution of materials to clinical trial sites.
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Project ManagerSomalogic Apr 2001 - Apr 2002Boulder, ColoradoAs Process/Project Manager, I developed a process-driven research and development infrastructure. This required facilitating the development of annual operational plans as well as managing cross-departmental product development processes in support of larger organizational strategy. -
Project ManagerThermobiostar 1997 - 2001Boulder, Colorado, United StatesAs Project Manager, I engaged in a range of project management activities for product development opportunities funded by the company and/or its strategic partners. This required managing multiple interdepartmental project teams and implementing product design control process.
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Regulatory Affairs AssociateAtrix Laboratories 1996 - 1997Fort Collins, Colorado, United StatesAs Regulatory Affairs Associate, I participated in preparation of new drug application for ATRIDOX® delivery system for periodontal disease. This included conducting reviews of product batch records, specifications, and other SOPs as well as developing and reviewing clinical trial protocols. -
Pre-Clinical Project CoordinatorAtrix Laboratories 1993 - 1996Fort Collins, Colorado, United StatesAs Pre-Clinical Project Coordinator, I organized and facilitated in vivo research/GLP studies at contract facilities. This included developing protocols for both research and GLP in vivo studies as well as monitoring pre-clinical studies to ensure proper GLP adherence to protocols.
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Research Associate/Animal Care SupervisorInhausen Research 1992 - 1993Fort Collins, Colorado, United StatesAs Research Associate and Animal Care Supervisor, I managed animal studies involving the testing of pharmaceutical and biological products. This required demonstrating a strong working knowledge of GLP procedures in accordance with FDA, EPA, and USDA guidelines.
Susan M. Skills
Susan M. Education Details
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Animal Science
Frequently Asked Questions about Susan M.
What company does Susan M. work for?
Susan M. works for Glm Quality Research Consulting, Llc
What is Susan M.'s role at the current company?
Susan M.'s current role is Retired but open to short-term projects.
What is Susan M.'s email address?
Susan M.'s email address is s.****@****ast.net
What is Susan M.'s direct phone number?
Susan M.'s direct phone number is (866) 852*****
What schools did Susan M. attend?
Susan M. attended Colorado State University.
What skills is Susan M. known for?
Susan M. has skills like Leadership, Regulatory Intelligence, Consulting, Clinical Trials, Medical Writing, Cro, Gmp, Infectious Diseases, Regulatory Filings, Clinical Research, Regulatory Documentation, Maa.
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Susan Lutz
New York, Ny3gmail.com, etsec.com, forcepoint.com1 +185622XXXXX
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