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Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

CMC-Development Regulatory Associate


Reference:SCARWS-072446 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

CMC – Development Regulatory Associate
Our client, a global pharma company are currently recruiting for a CMC Development Regulatory Associate to join their team on a permanent basis.As CMC Development Regulatory Associate you will create and manage submission documents and provide guidance on structure and content placement. You will work within regulations to expedite the registration and lifecycle maintenance of products, to ensure delivery of safe and effective products to patients.The scope of work includes global regulatory requirement assessment and understanding strategy development in relation to submission management.


Responsibilities

  • Partner with the CMC Regulatory Scientists to drive the execution of submission planning for clinical trials and global registration submissions. This includes defining key requirements for individual countries and managing questions from affiliates and agencies, establishing and monitoring content due dates, and executing the integrated regulatory strategy to ensure timely submissions
  • Review regulatory strategies across molecules and identify opportunities to simplify and streamline submissions for markets and/or regions
  • Interpret and implement global agency regulations, guidance and regulatory precedence into submission processes and publishing standards to ensure final document content and structure are compliant with local regulatory requirements
  • Lead CMC submission management process by providing expertise on internal processes, electronic submission regulations and guidance regarding technical content and structure requirements
  • Own the submission management process at the molecule/project submission level to ensure all required electronic records are timely, complete, and accurate
  • Serve as the CMC operational lead for global clinical trial applications and registration planning and execution, including critical chain status updates. Own execution of the right to operate routine compliance submissions, such as CMC annual reports (i.e. DSURs)
  • Understand and support the regulatory processes that enable review and release of clinical trial materials
  • Manage CMC databases and/or information tools, prepare periodic or special request submission metrics reports to enable CMC staff to identify and address global agency trends
  • Lead CMC submission management processes by leveraging expertise to optimize internal processes and tools. Anticipate and resolve process and/or timeline issues
  • Partner with the Regulatory Scientist to plan, facilitate and document internal regulatory draft review meetings, and/or submission integration/planning sessions
  • Guide and influence development teams and functions regarding internal and Agency life-cycle management processes and requirements
  • Subject matter expert (SME) responsible for the technical evaluation, implementation and documentation of CMC regulatory content, submission procedures/guidance, submission integration, and submission tracking
  • Comprehensive knowledge of evolving global agency publishing standards
  • Demonstrate expertise at planning CMC submissions
Requirements
  • BSc Degree qualified in a related field
  • Industry-related experience
  • Combination of industry/regulatory business and/or technical knowledge and skills developed through education and experience
  • Knowledge of drug development process
  • Demonstrated ability to manage operational requirements in a regulated environment
  • Demonstrated written, spoken, and presentation communication
  • Demonstrated negotiation and influence skills
  • Demonstrated attention to detail
  • Demonstrated ability to effectively prioritize and manage competing priorities and responsibilities
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal ss