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Details

CMC Regulatory Affairs Senior Manager


Reference:SCAHLK-316814 Location: Cork
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

CMC Regulatory Affairs Senior Manager

Our client, a global pharmaceutical organisation based in Cork are currently recruiting for a CMC Regulatory Affairs Senior Manager to join their global regulatory affairs group on a permanent basis. As CMC Regulatory Affairs Senior Manager you will manage the CMC submission management processes by leveraging expertise to optimize internal processes and tools.


Responsibilities

  • Manage the CMC submission management processes by leveraging expertise to optimize internal processes and tools processes and tools. Anticipate and resolve process and/or timeline issues across the global regulatory affairs group.
  • Understand and implement global agency regulations, guidance’s and regulatory precedence into the group’s RA submission processes and publishing standards to ensure final document content and structure are compliant with local regulatory requirements
  • Leverage internal and external forums to continue to develop and share submission management processes
  • Guide and influence teams and functions regarding internal and agency life-cycle management processes and requirements
  • Resolve identified global CMC regulatory issues
  • Communicate issues to Director and CMC Leadership as appropriate
  • Direct resources and prioritizes projects within the team, in order to manage workload across submission management team, in order to meet key deliverables across multiple customers including Manufacturing & Development
  • Lead the team to deliver on communicated operational/organisational targets
  • Develop productive relationships to enable the development of quality submissions in a timely fashion
  • Partner with the leadership teams and scientists to resource the planning and execution of regulatory draft review meetings, and/or submission integration/planning sessions
  • Knowledge of ICH CTD and evolving global agency publishing standards
  • Understand the drug development and manufacturing process,
  • Develop and manage key metrics to monitor workload and demonstrate value/quality

Requirements

  • Degree or higher degree in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience
  • 5-7 years industry related experience
  • Knowledge/awareness of Agency submission procedures and practices, and emerging submission electronic standards
  • Knowledge of drug development and/or manufacturing process, regulatory/business strategies and plans
  • Ability to operate and manage operational requirements in a regulated environment
  • Excellent written, spoken and presentation communication
  • Strong negotiation and influencing skills
  • Excellent attention to detail
  • Expertise in developing and implementing process controls and system metrics
  • Ability to effectively prioritize and manage competing priorities and responsibilities
  • Effective teamwork skills; able to adapt to diverse interpersonal ss