Job Summary

In this role you will provide leadership in all regulatory and submissions related aspects of the clinical trial, you will be the main client contact and will be responsible for delivering submission specific milestones, while also providing guidance to the client on submissions strategies.

  • Minimum Qualification: Degree
  • Experience Level: Senior level
  • Experience Length: 3 years

Job Description/Requirements

Xcene Research is currently looking for an experienced Regulatory Specialist to provide operational and business clinical trials for sub-mission in Sub-Saharan Africa.

As a Regulatory Specialist, you will be involved in operational aspects of Sub-Saharan Africa implementation and take on the role of Clinical Trial Submission Coordinator ensuring transversal collaboration between departments, working towards the delivery of all submissions of complex large clinical trials.

Role Responsibilities:

  • Drives global submission management strategy and activities for assigned protocols.
  • Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required.
  • Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities.
  • Support and leads global team efforts to ensure high-quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
  • Liaises with Core team, SSU and Study Management, regarding essential core documents and local documentation as need from relevant supplier lines across both HA and EC submission and translation processes.
  • Prepare, review and submit submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
  • Responsible for the co-ordination of translations for core documents required for submission.
  • Manages the compilation for core package build, contributing to CTA and authoring documentation as required.
  • Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
  • Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
  • Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project-specific information.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines.
  • Ensure monitoring measures are in place and implement contingency plans as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, ICF and IP Release documents, in line with project timelines.
  • Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
  • Perform quality control of documents provided by sites.


The ideal candidate will possess: 


Pharm D

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