Xcene Research is a cutting-edge Contract Research Organization providing full-service support to pharmaceutical, biotechnology and medical device companies as well as academic institutions.
Job Title: Regulatory Specialist
Employment Type: Full Time
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.
- 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:
The above statements are intended to describe the general nature and level of work to be performed by people assigned to this job.
They are not to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
All personnel may be required to perform other responsibilities in addition to those specified from time to time, as needed
• We do not charge any application, processing, training, interviewing, testing or other fee in connection with the application or recruitment process. Should you receive a solicitation for the payment of a fee, please disregard it. Furthermore, please note that emblems, logos, names and addresses are easily copied and reproduced. Therefore, you are advised to apply particular care when submitting personal information on the web
• We are an equal opportunity employer and value diversity inclusion. We do not discriminate on grounds of colour, race, nationality, religion, age, ethnic origin, disability, gender, marital status, or sexual orientation in our employment practices
• Our people are all equally gifted in unique ways: we come from diverse traditions, personal experiences and points of view. And we want to include yours, Are you ready to inspire us with your ideas?
• We encourage all applicants to apply and does not practice any discrimination in any recruitment process.
• Applications submitted after the deadline will not be considered.
• Due to the urgency of the position, we have the right to recruit a candidate who matches the required profile before the above deadline
• Only qualified candidates will be invited for interview
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