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Director, Global Regulatory Policy

Company: Public Affairs Council
Location: Rockville
Posted on: September 15, 2020

Job Description:

We're looking for a candidate to fill this position in an exciting company.

  • ´╗┐Defining and delivering a regulatory policy plan that addresses current and future business needs, that is co-designed with Global Regulatory Affairs and Clinical Safety Vaccines & Infectious Diseases leadership and in partnership with our company's policy teams at the global, regional and country levels;
  • Propose - and respond to - draft legislation, regulations, guidelines and policies--at the US level and provide therapy level support to regional and country teams globally for national guidance; Plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters.
  • Advocate for and anticipate regulatory change with--Europe, Middle East, Africa-based globally leading regulators and EMEA-focused multilateral organisations;
  • Manage on-site activities for select meetings with FDA and other health authorities (e.g., regulatory milestone meetings, management "meet and greets", ad hoc policy-focused meetings) as assigned for specific projects.
  • Providing insights and advocate for positions--on critical regulatory issues and trends to Research and Development business partners and to contribute to a broader policy platform; and
  • Build our company's share of voice and influence extramural to support the enterprise policy agenda through engagement in trade associations and representation for industry initiatives.´╗┐
    • Bachelor's Degree is required, preferably in science, health care, public health or health policy or BS in any field accompanied by a Master's or Doctorate degree in science, health care, public health, health policy, or law
    • Doctorate degree and at least 5 years' experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority OR
    • Master's degree and at least 8 years' experience with FDA or other health authority, either directory (working within a health authority) or indirectly (closely interacting with health authority) OR
    • Bachelor's degree and at least 10 years' experience with FDA or other health authority, either directly (working within a health authority) or indirectly (closely interacting with health authority)

Keywords: Public Affairs Council, Rockville , Director, Global Regulatory Policy, Executive , Rockville, Maryland

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