Mark Learn

About Mark Learn

Senior leader guiding largest US tobacco company through legal and regulatory challenges of new FDA paradigm. Recognized for developing strategies and legal positions that obtain positive results and advance organizational goals. Praised for collaborating with leaders across the enterprise to achieve successful business outcomes. Previously spent over 20 years within or counseling pharmaceutical and biotechnology companies regarding FDA regulation and drug development.

Experience

1. Sr Assistant General Counsel

   Altria

   Apr 2018 — Present · Richmond, VA, US

   Leads corporate legal and regulatory strategy through historic change in FDA law. Provides counsel to the Enterprise and its Senior Executive Leadership Team regarding legal and business strategies consistent with the corporate mission and achieving demanding business goals. Counsels in an extremely fast-paced and high-stakes legal environment that includes constant ongoing and future products liability and regulatory litigation, general and public health criticisms of products and business practices, and an uncertain FDA regulatory landscape including: • all issues relating to FDA tobacco, drug, and food regulation including statutory interpretation, likely FDA implementation and policy positions, business and legal risks and solutions, and overall and specific regulatory and compliance strategies; • all legal and regulatory aspects of preclinical and clinical investigations of new technologies and products, manufacturing standards, promotional claims substantiation, ingredient safety, and FDA jurisdictional issues; • legal and regulatory strategies for high profile regulatory submissions criticizing FDA’s proposed regulations and Guidance documents including dozens of public docket filings; • obtaining marketing clearances for Operating Companies’ tobacco products including multiple successful substantial equivalence determinations as well as PMTA and MRTP submissions; and • issue spotting in collateral legal areas as diverse as co-employment, product liability, anti-trust, reputational risks, privacy, intellectual property, contracting, vendor relations, media perceptions, etc.

Education

• Temple University - James E. Beasley School of Law

  JD, Law

  1994 — 1998

• University of Maryland College Park

  BS, Zoology

  1979 — 1983