GlaxoSmithKline: Global Regulatory Affairs and Policy Fellowship

OBJECTIVES: 

  • Understand the laws, regulations, and policies that govern pharmaceutical product development.
  • Execute tactics that support the overall regulatory strategy for GSK portfolio medicines and/or new indications or label extensions.
  • Collaborate within cross-functional teams on daily activities and special projects of Global Regulatory Affairs (GRA).
  • Gain experiential proficiency within the assigned track.
  • Regulatory Advertising and Promotion Policy (RAPP): Assist in content development and review of labeling and promotional materials.
  • Global Regulatory Policy and Intelligence (GRPI) : Conduct strategic reviews of the regulatory environment to identify trends in policy direction and potential impact to the business.
  • NEW in 2025 Labeling: Support the generation of competitive labeling strategies and compliant labeling content for development and marketed products.

ROTATIONAL STRUCTURE: 

1st Rotation Howard University (6 months) Fellows will complete coursework and training through the Howard University College of Pharmacy and School of Law to gain exposure to academia, learn the scientific process for research design and methodology, and obtain professional certification in pharmaceutical regulations proficiency.

2nd Rotation GSK (18 months) The first 6 months of the GSK rotation will run concurrently with the Howard rotation. Fellows will gain experience across a specialized regulatory discipline of Global Regulatory Affairs - Regulatory Advertising and Promotion (RAPP), Global Regulatory Policy and Intelligence (GRPI), or Labelling - and learn about the principles for drug development strategies, regulatory submissions and agency reviews and approvals.

3rd Rotation FDA (6 months) Fellows will be assigned to one of two tracks in the Office of Medical Policy to receive hands- on training in FDA regulations and policy: Patient Labeling, where fellows will review and revise patient labeling documents for approval; Regulatory Policy, where fellows develop policy documents and evaluate and propose responses to public comments.

Recruiting Global Regulatory Affairs and Policy is recruiting two (2) positions.

INTERVIEW:

Interviews for Global Regulatory Affairs and Policy Fellowships will be conducted virtually through mid-December 2024 and candidates will be selected by end of December 2024.

ELIGIBILITY REQUIREMENTS:

Application Process Requirements for Eligibility Fellows for the Howard University-GSK Pharmaceutical Industry Fellowship Program are selected on a nationally competitive basis. Candidates must have completed a Doctor of Pharmacy (PharmD) or Doctor of Philosophy (PhD) degree from an ACPE-accredited institution prior to commencement of the fellowship term.

PROGRAM DIRECTOR:

Brandy Proctor, MS Regulatory Policy Manager Global Regulatory Policy and Intelligence (GRPI)

GRA EARLY TALENT PROGRAMS LEAD:

Jonathan LaCalamita VP and Head US Regulatory Advertising and Promotion Policy

PRECEPTORS:

  • Rob Berlin Head, US Regulatory Policy Global Regulatory Policy and Intelligence (GRPI)
  • Cheryl Jones Director, Regulatory Advertising and Promotional Policy (RAPP)
  • Brittany Galop Labelling Strategy and Development
  • Marcella Paglione Regulatory Affairs Management
  • Michelle Carfagno Regulatory Affairs Management
  • Shreya Parikh Labelling Development
APPLY HERE