Brian Kelley

Brian Kelley Email and Phone Number

Development and Regulatory Counsel @ Mitsubishi Chemical America
Washington, DC, US
Brian Kelley's Location
Washington DC-Baltimore Area, United States, United States
Brian Kelley's Contact Details

Brian Kelley personal email

About Brian Kelley

As a trusted legal advisor and highly respected consultant, I’ve been called upon throughout my legal career to lead corporate entities operating in the pharmaceutical, healthcare, and medical device markets to ensure ethical navigation of laws, policies, and guidelines associated with corporate research and development, clinical trials, licensing, product marketing, privacy matters, and regulatory compliance in both domestic and international arenas. I am also well-versed in enforced in compliance standards enforced by the European Union (EU) and those outlined within Good Clinical Practice (GCP) principles.

Brian Kelley's Current Company Details
Mitsubishi Chemical America

Mitsubishi Chemical America

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Development and Regulatory Counsel
Washington, DC, US
Brian Kelley Work Experience Details
  • Mitsubishi Chemical America
    Development And Regulatory Counsel
    Mitsubishi Chemical America
    Washington, Dc, Us
  • Mitsubishi Tanabe Pharma America
    Senior Development & Regulatory Counsel
    Mitsubishi Tanabe Pharma America Jun 2023 - Present
    Jersey City, Nj, Us
    Supporting Mitsubishi Tanabe Pharma America providing advice on legal and compliance issues as they arise from the clinical, safety, regulatory, medical, sourcing and executive teams.Supporting all aspects of the healthcare and pharmaceutical development business and operating as part of teams developing pipeline products in the U.S. and acquiring or licensing products in the U.S. Responsible for evaluating strategic and tactical research and development and business development plans and advising clients on a broad array of issues relating to FDA pharmaceutical regulations, GxP regulations, product development, product labeling, non-promotional-reviews, anti-trust, anti-kickback, competitor issues, compliance issues, regulatory policy, medical, industry and group company issues.
  • Paragon Legal
    Legal Counsel
    Paragon Legal Nov 2022 - Jun 2023
    Supporting legal affairs department of a pharmaceutical company in the neurodegenerative disease space. Providing consultation on privacy law related matters including consultation regarding GDPR and CCPA.
  • Paragon Legal
    Legal Counsel
    Paragon Legal Sep 2022 - Jun 2023
    San Francisco, California, Us
    Counsel at Paragon Legal, a premier legal services firm providing interim in-house counsel to leading corporate legal departments. Currently on engagement supporting a leading innovator in RNA-targeted pharmaceutical therapies with negotiations and drafting of clinical research related agreements.
  • Otsuka America Pharmaceutical, Inc.
    Senior Corporate Counsel
    Otsuka America Pharmaceutical, Inc. Sep 2008 - Jun 2022
    Practice Group Leader, Global R&D Practice Group
  • U.S. Department Of Health And Human Services
    Attorney
    U.S. Department Of Health And Human Services Apr 2002 - Aug 2008
    Washington, District Of Columbia, Us

Brian Kelley Skills

Litigation Intellectual Property Legal Research Licensing Corporate Law Legal Writing Administrative Law Pharmaceutical Industry Commercial Litigation Privacy Law Management Strategic Planning

Brian Kelley Education Details

  • American University Washington College Of Law
    American University Washington College Of Law
    The Law
  • Emory University
    Emory University
    Political Science

Frequently Asked Questions about Brian Kelley

What company does Brian Kelley work for?

Brian Kelley works for Mitsubishi Chemical America

What is Brian Kelley's role at the current company?

Brian Kelley's current role is Development and Regulatory Counsel.

What is Brian Kelley's email address?

Brian Kelley's email address is br****@****-us.com

What schools did Brian Kelley attend?

Brian Kelley attended American University Washington College Of Law, Emory University.

What skills is Brian Kelley known for?

Brian Kelley has skills like Litigation, Intellectual Property, Legal Research, Licensing, Corporate Law, Legal Writing, Administrative Law, Pharmaceutical Industry, Commercial Litigation, Privacy Law, Management, Strategic Planning.

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