GlaxoSmithKline-posted about 1 year ago
Full-time • Mid Level
Hybrid • Collegeville, PA
5,001-10,000 employees
Chemical Manufacturing

The Associate Director, Regulatory Asset Oversight will collaborate with various teams to provide comprehensive project management support for active Rx and Vx projects throughout their lifecycle. This role involves creating and managing integrated regulatory plans to operationalize the Global Regulatory Strategy (GRS) and ensuring that the team meets regulatory delivery expectations. The position requires effective interaction across enterprise matrix teams and engagement with key partners outside of regulatory to facilitate submission delivery and compliance.

  • Develop and maintain a holistic view of the global regulatory integrated plan at the asset level.
  • Drive the execution of agreed plans to ensure timely delivery per the Global Regulatory Strategy (GRS).
  • Perform scenario planning, impact analyses, and critical path analyses to facilitate risk mitigation.
  • Assist Regulatory Matrix Teams (RMTs) and Global Regulatory Leads (GRLs) with submission delivery strategies.
  • Ensure alignment of submission delivery strategy with the Global Submission Strategy (GSS).
  • Act as a Single Point of Contact with RMTs and Submission Delivery Excellence colleagues to identify and remove barriers to success.
  • Promote and drive the use of Regulatory technologies for real-time submission status information.
  • Degree in a biological, healthcare, or scientific discipline or relevant experience in drug development.
  • Minimum of 3 years experience in the pharmaceutical industry or regulatory environment overseeing multiple activities across assets.
  • At least 3 years experience in Regulatory Affairs from pre-IND through Post-Approval.
  • 3 years or more experience in project management and resource management systems.
  • Professional experience in a Submission delivery or Project Management role.
  • Ability to effectively lead multidisciplinary team meetings and discussions.
  • Good written and verbal communication skills.
  • Ability to interact effectively with different levels in the regulatory organization and persuade stakeholders.
  • Ability to gain consensus in complex environments and proactively identify risks.
  • Competitive salary
  • Annual bonus based on company performance
  • Healthcare and wellbeing programmes
  • Pension plan membership
  • Shares and savings programme
  • Hybrid working model through Performance with Choice programme
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