GlaxoSmithKline-posted about 1 year ago
Full-time • Mid Level
Collegeville, PA
Chemical Manufacturing

The CMC Development Projects Regulatory Project Manager at GSK is responsible for managing multiple regulatory projects and teams, ensuring successful regulatory outcomes. This role involves developing CMC strategies, preparing submission documents, and maintaining high-quality standards while navigating the evolving regulatory landscape. The position requires collaboration across various departments to expedite the submission and approval of global CMC applications.

  • Manage global CMC regulatory activities for assigned projects.
  • Develop CMC strategies for submission documents from early-phase clinical submissions to marketing applications.
  • Advise teams on regulations, guidelines, and policies related to medicinal product development and registration.
  • Work in cross-functional matrix project teams including regulatory, development, quality, and manufacturing colleagues.
  • Maintain high-quality standards and drive continuous improvement in regulatory processes.
  • Bachelor's Degree in pharmacy, chemistry, or a related scientific discipline.
  • Minimum of 2 years of experience in drug development/manufacturing processes.
  • Minimum of 1 year of experience in CMC regulatory affairs or product development with direct involvement in regulatory submission preparation.
  • Broad-based knowledge across regulatory functions to understand wider implications of emerging issues.
  • Experience influencing and negotiating with regulatory agencies and within the organization.
  • Ability to find innovative solutions to complex problems.
  • Good time-management skills to prioritize and coordinate multiple tasks.
  • Strong verbal and written communication skills with attention to detail.
  • Excellent team working abilities.
  • Comprehensive benefits program including health insurance, retirement plans, and wellness programs.
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