Jeffrey Dow, Jd Email and Phone Number
Jeffrey Dow, Jd work email
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Jeffrey Dow, Jd personal email
Do you need contract or special project help with FDA submissions or compliance? I have 40 years’ experience with FDA regulations, guidances, and its staff. I am a SENIOR REGULATORY EXECUTIVE with expertise in designing and implementing comprehensive Regulatory, Clinical, and Operating strategies to advance companies committed to world-class innovation in Pharmaceutical, Biologic / Biotechnology and Medical Device Development.Diverse industry perspectives derived through C-level and senior management leadership in multinational, market-leading corporations (Hoffmann-La Roche, Johnson & Johnson (J&J), Kendall, American Red Cross, Synthes), as well as emerging companies. INDUSTRY INSIGHTS ► Responsive to changing US and EU business, market and regulatory trends impacting product development and commercialization. Devised and implemented strategies, processes, and standards to mitigate regulatory risk and accelerate application submission, approval and launch.TEAM BUILDING AND QUALITY LEADERSHIP ► Effective leadership of lifecycle development initiatives, US / EU regulatory submissions, and internal quality and compliance audits. Instill loyalty and trust, and forge collaboration among clinical, scientific, engineering, operational and business groups to achieve operational effectiveness, high quality standards, and ongoing compliance.REGULATORY AUTHORITY ► Recognized strategist, policy expert and chief biomaterials liaison for J&J to Food & Drug Administration (FDA), including Commissioner’s Office, Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Office of Combination Products (OCP), and Veterinary Medicine. Liaison to EU Notified Bodies and Competent Authorities. Effective overseer of competitive drug/device claims.Contact me at jeffreydow@outlook.com
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Senior Principal R And A Strategy Advisor, BiomaterialsJohnson & JohnsonPhiladelphia, Pa, Us -
Senior Principal R/A Strategy Advisor, BiomaterialsJohnson & Johnson 2006 - PresentServed as senior regulatory executive. Advanced Company’s global leadership position through proactive clinical, regulatory, and compliance strategies, plans, and processes. Oversaw product lifecycle management. Accelerated product development and approvals for high-value portfolio of IP in climate of ongoing industry and regulatory change across US and European Union.HIGHLIGHTED ACHIEVEMENTS:• Strategized regulatory pathway for submissions, reviewing and approving for US… Show more Served as senior regulatory executive. Advanced Company’s global leadership position through proactive clinical, regulatory, and compliance strategies, plans, and processes. Oversaw product lifecycle management. Accelerated product development and approvals for high-value portfolio of IP in climate of ongoing industry and regulatory change across US and European Union.HIGHLIGHTED ACHIEVEMENTS:• Strategized regulatory pathway for submissions, reviewing and approving for US 510(k), IDE and PMA device applications for Class II and Class III devices; IND submissions for drug combination product, and EU Technical Files or Design Dossiers for Class I, IIa, IIb and III devices.• Outlined and presented compelling arguments against proposed clinical trial requirements that would have adversely impacted market timing, cost-effectiveness, and economic value of 3 platform technologies under development.• Oversaw biomaterials compliance with UDI requirements. Show less
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Director Regulatory AffairsNoven Pharmaceuticals 2004 - 2006Miami, FlDeveloped multi-dimensional regulatory strategies. Brought FDA approved applications to market for women’s health, pediatrics, and psychiatry. Served as lead FDA communicator / mediator and executive counsel on clinical trials and joint marketing partnership development.HIGHLIGHTED ACHIEVEMENTS:• Prepared NDA submission, achieving FDA approval for 1st methylphenidate transdermal delivery system indicated as treatment for ADHD.• Amended regulatory strategies, addressing… Show more Developed multi-dimensional regulatory strategies. Brought FDA approved applications to market for women’s health, pediatrics, and psychiatry. Served as lead FDA communicator / mediator and executive counsel on clinical trials and joint marketing partnership development.HIGHLIGHTED ACHIEVEMENTS:• Prepared NDA submission, achieving FDA approval for 1st methylphenidate transdermal delivery system indicated as treatment for ADHD.• Amended regulatory strategies, addressing FDA concerns and revising ANDA application for fentanyl transdermal system for narcotic pain medicine. Show less -
Vice President, General Counsel & SecretaryOrganogenesis Inc. 1998 - 2003Boston, MaWorked with newly appointed CEO. Implemented new business model and closed substantial budget gaps. Monetized previously patented technology. Led comprehensive restructuring to reduce costs, protect intellectual property, and led business through Chapter 11 reorganization.HIGHLIGHTED ACHIEVEMENTS:• Reduced FDA approval cycle time by changing submission to qualify for 510(k) clearances.• Drove $17M in costs out of business, including 70% headcount reduction, and placing… Show more Worked with newly appointed CEO. Implemented new business model and closed substantial budget gaps. Monetized previously patented technology. Led comprehensive restructuring to reduce costs, protect intellectual property, and led business through Chapter 11 reorganization.HIGHLIGHTED ACHIEVEMENTS:• Reduced FDA approval cycle time by changing submission to qualify for 510(k) clearances.• Drove $17M in costs out of business, including 70% headcount reduction, and placing company on trajectory for achieving profitability and increasing revenue more than 200% over 2-year period. Show less
Jeffrey Dow, Jd Education Details
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Doctor Of Law (J.D.) -
English And History Majors
Frequently Asked Questions about Jeffrey Dow, Jd
What company does Jeffrey Dow, Jd work for?
Jeffrey Dow, Jd works for Johnson & Johnson
What is Jeffrey Dow, Jd's role at the current company?
Jeffrey Dow, Jd's current role is Senior Principal R and A Strategy Advisor, Biomaterials.
What is Jeffrey Dow, Jd's email address?
Jeffrey Dow, Jd's email address is jd****@****ano.com
What schools did Jeffrey Dow, Jd attend?
Jeffrey Dow, Jd attended University Of Pennsylvania Law School, Duke University.
Who are Jeffrey Dow, Jd's colleagues?
Jeffrey Dow, Jd's colleagues are Bala Motwani, Yuh Nakano, Shawn Miller, Tracy Norman, Lechyna Mitchell, Kiran Rajbhar, Arve Stokke.
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