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Sinead Cullen
Life Science

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Details

Clinical Regulatory Associate


Reference:SCALET-012355 Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs Clinical Research, Clinical Trials Advisor, Clinical Research Nurse, Clinical Research Associate

Clinical Regulatory Associate
Our client, a global pharma company are currently recruiting for a Clinical Regulatory Associate to join their team on a permanent basis. As Clinical Regulatory Associate you will beaccountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients.


Responsibilities

  • Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content for which includes INDs, NDA, BLAs, NDSs, and other eCTD MAAs, and ensuring compliance with all applicable regulations and internal quality systems with a focus on delivery of the development portfolio across all modules of the CTD
  • Partner with other geographies to understand and incorporate local agency regulations and requirements as needed. For example, lead the planning and execution for electronic submissions in those regions who have and are adopting the eCTD specification
  • Guide and influence development team and function regarding internal and Agency registration management processes and requirements
  • Own the registration management process at the molecule/project level to ensure all required electronic records are timely, complete, and accurate for the the IND and NDA submissions. Tracking the status of pending applications
  • Operational lead for registration planning and execution including but not limited to: critical chain planning sessions and status updates, team operation meetings
  • Own the routine compliance submissions and processes (e.g. DSUR, NDA/BLA annual reports, PSUR/PADER, routine maintenance submissions
  • Partner with the Regulatory Coordinator/Scientist to drive the execution of the product deletion, divestiture process, IND inactivation/withdrawal process, product withdrawal process
  • Provide registration management expertise to the due diligence and business development processes
  • Serve as the registration management expert for other processes dependent upon the registration record
  • Partner with the Regulatory Scientist to plan, facilitate and document internal, FDA, and partner meetings
  • Leverage internal and external forums to continue to develop and share regulatory, drug development, and therapeutic expertise
  • Influence others in a manner that creates maximum advantage for the organization
  • Communicate verbally and in writing to effectively influence within work group/function and with development team

Requirements



  • A BS or higher degree in a technical discipline such as chemistry, biology, pharmacy or equivalent demonstrated industry experience
  • Knowledge of drug development process
  • Demonstrated ability operate and manage operational requirements in a highly regulated environment
  • Demonstrated effective written, spoken and presentation communication
  • Demonstrated effective negotiation and influence skills
  • Demonstrated attention to detail
  • Demonstrated effective teamwork skills; able to adapt to diverse interpersonal ss