Regulatory Compliance Manager

4 weeks ago

North East, United Kingdom GlaxoSmithKline Full time
Job Description

Job Title: Regulatory Compliance Manager

Job Summary: We are seeking a highly skilled Regulatory Compliance Manager to join our team at GlaxoSmithKline. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and guidelines related to promotional activities.

Key Responsibilities:

  • Provide support to US Commercial and ViiV Healthcare, US Operations, and US Regulatory Advertising and Promotions staff in governing the enterprise content review/approval/distribution/submissions Standard Operating Procedures framework.
  • Ensure mandatory electronic submissions of promotional activities to the FDA.
  • Train staff on processes, as needed.
  • Manage workload priorities, promotional filing compliance, and effective matrix relationships with Regulatory Advertising and Promotion Teams, Global Regulatory Publishing, US Ethics & Compliance, US Content Strategy & Operations, and US Commercial Marketing stakeholders across all US Business Units.

Requirements:

  • Associates Degree or equivalent experience in Pharmaceutical and/or Regulatory operations.
  • Regulatory and/or compliance operations; promotional review, approval, and regulatory submissions requirements.
  • 3 plus years of experience working in Pharmaceutical Commercial Operations OR Regulatory Operations.

About Us: GlaxoSmithKline is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.

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