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Regulatory Affairs Director

2 months ago

New Providence, Iowa, United States 1925 GlaxoSmithKline LLC Full time

Job Title: Precision Medicine and Digital Health Regulatory Strategist

Company: 1925 GlaxoSmithKline LLC

Description:

Purpose: Develop and execute comprehensive regulatory plans for assigned assets within the company's therapeutic portfolio. Ensure compliance with internal processes and regional regulations to achieve optimal product labeling based on available data.

Key Responsibilities:

  • Develop and implement regional regulatory strategies and deliver them in a timely manner
  • Collaborate across departments and with external partners to represent the company's interests
  • Lead regulatory interactions and review processes to ensure compliance
  • Provide strategic guidance on Precision Medicine and Digital Health for potential in-license molecules

Essential Competencies:

  • Strategic thinking and problem-solving skills
  • Effective communication and collaboration skills
  • Ability to lead change and resolve conflicts
  • Sound decision-making skills considering available information

Qualifications:

  • Master's Degree in a relevant field, such as biological science, healthcare science, or engineering
  • Experience in regulation of companion diagnostics and SaMD
  • Led global development, submission, and approval activities
  • Knowledge of clinical trial and licensing requirements for Precision Medicine and Digital Health Products

Preferred Qualifications:

  • Excellent communication and interpersonal skills
  • Ability to foster matrix working and lead change
  • Build strong networks and derive creative solutions to regulatory problems