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Regulatory Project Leader

2 months ago

Boston, Lincolnshire, United Kingdom SoftPathTechnologies Full time
Position: Project Manager

Location: SoftPathTechnologies

Work Schedule: In-office Monday to Wednesday; Remote Thursday and Friday

Key Responsibilities:
  • Formulating and overseeing regulatory strategies for various projects
  • Acting as the primary contact for designated programs
  • Offering regulatory guidance for product development
  • Crafting and implementing regional regulatory plans
  • Representing the organization in discussions with regulatory bodies
  • Leading submissions to US regulatory authorities
  • Keeping abreast of regulatory requirements and guidance updates
  • Assisting in due diligence processes
  • Encouraging ethical practices and exemplary conduct
Qualifications:
  • Comprehensive understanding of US pharmaceutical development and regulations
  • Proven experience in delivering strategic regulatory counsel
  • Capability to manage intricate projects effectively
  • Excellent interpersonal and communication abilities
  • Demonstrated history of sound judgment and risk evaluation
  • Awareness of emerging regulations and guidance
  • Bachelor's Degree in a relevant field