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Aggressive and experienced Chief Strategy Officer with deep knowledge of Sales, Compliance, and Regulatory Affairs with a background reflecting consistent career progression and achievement of objectives; demonstrated expertise in effective cost-effective regulatory affairs strategies and management processes complemented by strong interpersonal skills. Excellent public speaker with an ability to communicate effectively and precisely via print and public appearances.Able to efficiently manage multiple projects simultaneously; maintain a vast wealth of knowledge in many areas, including directing all aspects of the regulatory processes, establishing multiple institution channels and negotiating with various regulatory bodies both foreign and domestic; proven ability to establish strong business relationships, and immediately contribute to operations. Empowered and highly motivated individual, results oriented and extremely organized, excellent communication, relationship-building skills and a team player known for ability to relate to clients and build lasting market share for years to come.
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Director Of OperationsFflguard Nov 2023 - PresentNew York, Us -
Chief Strategy OfficerGearfire Oct 2020 - Oct 2023Scottsdale, Arizona, Us -
Director, Implementation TechnologyGearfire Oct 2018 - Oct 2020Scottsdale, Arizona, Us -
Executive Director, Regulated ProductsOrchid Advisors - #1 In Ffl Compliance Oct 2018 - Oct 2019West Hartford, Connecticut, Us -
Operations ExecutiveOrchid Advisors - #1 In Ffl Compliance Nov 2016 - Oct 2018West Hartford, Connecticut, UsOrchid Advisors★ Our clients run the best and most compliant firearms manufacturing, distribution and retail businesses. In partnership with NSSF, NASGW, ASA and the NRA Business Alliance.♦ With our partners, we deliver the only integrated compliance, technology and legal solution. We host the only Firearms Compliance Conference, offer the most online ATF/ITAR courses, partner with the best law firms and provide the right technology solutions for your compliance needs.♦ We educate your team and inspect your ATF and ITAR / Export compliance.Awareness of the regulations and how they impact your FFL is the foundation of compliance. Our exclusive focus on ATF inspections and Export compliance allows us to train your personnel and uncover your risks efficiently. ♦ We build ATF and ITAR controls into FFL operations.Our unique expertise is the ability to embed compliance into an FFL’s business operations. Orchid drives compliance into your daily process and while growing your profits.♦ We help you fix ATF and ITAR / Export violations.If you are dealing with ATF or ITAR / Export violations, no firm is in a better position than Orchid Advisors to help you fix them. We are called upon for the industry’s largest inspections and routinely instill confidence with your regulators. Solutions♦ ATF Compliance & Inspections♦ ITAR / Export Compliance Programs♦ ATF e4473, eA&D and FFL ERP / POS Software♦ FFL Operations Consulting -
Executive DirectorFflbizhub.Com Aug 2017 - Oct 2018FFLBizHub.com★ Our clients run the best and most compliant firearms manufacturing, distribution and retail businesses. In partnership with NSSF, NASGW, ASA and the NRA Business Alliance.♦ We dramatically improve your regulated retail and manufacturing processes.We offer the only ATF e4473, NFA eForms and Electronic Bound Book software that is designed, migrated and implemented by an ATF compliance consulting firm. We don’t sell you software unless it improves your compliance.♦ We bring technology and regulation together in one place.We offer the only consolidated portal of Federal and State Regulations that is hosted along-side ATF e4473, NFA eForms, and Electronic Bound Book software. We don’t use ATF regulations as a buzz word to promote our software.Cloud-based Software Modules for FFLs♦ ATF eForms and Electronic Bound Book♦ ATF Regulations and State Firearm Laws♦ Firearm Serial Number Inventory♦ Training on FFL Compliance Requirements♦ FFL License and SOT Applications♦ Firearm Pricing Trends and eCommerce
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Compliance Manager, Firearms & OperationsEzcorp Sep 2014 - Oct 2016Rollingwood, Texas, Us Develop, implement, and monitor compliance programs for operating more than 500 retail locations across North America Author and update Firearms Compliance Manual, including operational compliance procedures for local, state, and federal agencies including ATF, FBI, law enforcement, and state firearms agencies Provide provisions of guidance regarding marketing initiatives for compliance and licensing requirements Regularly provide executive level guidance, summaries and presentations for compliance initiatives Interact with agencies including CFPB, ATF, FBI, FINCEN, and IRS Compliance and Due Diligence for acquisitions -
Project Management, Compliance & Regulatory Affairs Strategy ConsultantCompliance Consultants Oct 2013 - Aug 2014 Expertly review product promotional materials and marketing plans for compliance with PDMA and various international standards Provides detailed, careful reviews of compliance processes and execution for gaps in training for all processes to include GMP, Sales Force, and Executive Management Project Management for Compliance and Regulatory Affairs
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Regulatory AffairsAlk Abelló May 2012 - Oct 2013Hoersholm, Dk-2970, Dk Expertly review product promotional materials, labeling, and other corporate communications and strategies for compliance with applicable regulations and policies for drugs, biologics, and devices File for new registrations and maintain/renew existing foreign registrations for drugs, biologics, and devices Review regulatory files for technical accuracy of reports and submissions while coordinating regulatory efforts implemented by global organizational units Coordinate, prepare and review submissions to local and national agencies, including FDA, Health Canada, Israel MOH, FDA Thailand, South American Markets, EPA, OSHA and other agencies for drugs, biologics, and devices (510K, PMA, IVD, and IDE) Provide training of employees and contractors for compliance with local and global systems Develop and implement Compliance Program, Quality Systems, and approval strategies for local and global organization Serve as the ALK point person for Competent Authority Inspections, including Health Canada, FDA, and others Provide regulatory input and guidance regarding product development activities, business development and acquisitions, as well as promotional marketing communications -
SpecialistVaya Pharmaceuticals 2010 - 2012
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CeoDoodlebug & Peanut, Inc. Dec 2008 - Jan 2010
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Sales Representative IiTeva Specialty Pharmaceuticals Aug 2004 - Jun 2009Tel-Aviv, Il -
Pharmaceutical SalesBayer 2003 - 2004
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Pharmaceutical Sales RepresentativeMedpointe Pharmaceuticals/Organon Inc 2003 - 2003Us -
Sales RepresentativeOrganon 2001 - 2003Jersey City, Nj, Us -
NewmediaKswo Newmedia 2000 - 2001
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AssistantPlanned Marketing Associates 1994 - 1996
Alexis Tunell Skills
Alexis Tunell Education Details
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Tulane UniversityChemistry -
TivyHonors Diploma
Frequently Asked Questions about Alexis Tunell
What company does Alexis Tunell work for?
Alexis Tunell works for Fflguard
What is Alexis Tunell's role at the current company?
Alexis Tunell's current role is Operations & Strategy Expert.
What is Alexis Tunell's email address?
Alexis Tunell's email address is at****@****ors.com
What is Alexis Tunell's direct phone number?
Alexis Tunell's direct phone number is +151257*****
What schools did Alexis Tunell attend?
Alexis Tunell attended Tulane University, Tivy.
What skills is Alexis Tunell known for?
Alexis Tunell has skills like Pharmaceutical Industry, Pharmaceutical Sales, Regulatory Affairs, Medical Devices, Cardiology, Sales, Leadership, Product Launch, Managed Care, Sales Operations, Sales Effectiveness, Biotechnology.
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