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Details

CMC Regulatory Associate


Reference:SCAHGN-008282 Location: Cork
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

CMC Regulatory Associate
Our client, a global pharma company are currently recruiting for a CMC Regulatory Associate to join their team on a permanent basis.As CMC Regulatory Associateyou will lead and partner with Chemistry, Manufacturing and Controls (CMC) Regulatory Scientists in the various aspects of global marketing authorization submission management processes. You will build and manage submission content, provide guidance on structure and content placement within Common Technical Document (CTD) registration submissions, and to provide assistance with submission related questions. You will work within regulations to expedite the registration and lifecycle maintenance of products.


Responsibilities

  • Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements
  • Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products
  • Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions
  • Responsible for triage of inquires and requests and when necessary consults with CMC RA Scientist for guidance in effort to prepare responses to questions
  • Implement and in some cases interpret global regulations and guidance’s and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with regulatory staff, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements
Requirements
  • Bachelor’s Degree in a scientific or health sciences discipline (e.g. pharmacy, chemistry or related scientific discipline)
  • Knowledge of pharmaceutical drug development or industry-related experience preferred.
  • Drug development process or Industry-related experience
  • Knowledge of Agency submission procedures and practices. Knowledge / awareness of emerging submission electronic standards.
  • Ability to operate and manage operational requirements in a regulated environment
  • Written, spoken and presentation skills
  • Negotiation and influence skills
  • Attention to detail and ability to effectively prioritize
  • Proven effective teamwork skills; able to adapt to diverse interpersonal ss