Job Title: Country Approval Specialist
Location: Remote (UK Based)
Contract: 6 Months
Overview:
The Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission.
Responsibilities:
* Prepare, review, and coordinate local regulatory submissions (e.g., MoH, EC, gene therapy approvals, viral safety dossiers, import license) in alignment with the global submission strategy under guidance.
* Provide local regulatory strategy advice (MoH and/or EC) under guidance.
* Provide project-specific local Site Initiation Activities (SIA) services and coordinate these projects.
* Serve as a key contact at the country level for Ethical or Regulatory submission-related activities.
* Maintain contact with investigators for submission-related activities, as applicable.
* Coordinate with internal functional departments to align site start-up activities with submission activities and mutually agreed timelines.
* Ensure submission processes for sites and studies align with the critical path for site activation.
* Achieve target cycle times for site start-up activities.
* Collaborate with start-up CRA(s) to prepare regulatory compliance review packages, as applicable.
* Develop country-specific Patient Information Sheet/Informed Consent Form documents, as required.
* Assist with grant budgets and payment schedule negotiations with sites.
* Support coordination of feasibility activities according to agreed timelines.
* Enter and maintain trial status information related to SIA activities accurately and timely in tracking databases.
* Prepare, set up, and maintain local country study files and filing processes per applicable SOPs.
* Maintain knowledge and understanding of SOPs, directives, and current regulatory guidelines relevant to services provided.
Requirements:
* Bachelor’s degree.
* Effective oral and written communication skills.
* Excellent interpersonal skills.
* Strong attention to detail and quality of documentation.
* Good negotiation skills.
* Good computer skills and ability to learn relevant software.
* Proficient English language and grammar skills.
* Basic knowledge of medical/therapeutic areas and medical terminology.
* Ability to work independently or in a team environment under direction, as required.
* Basic organizational and planning skills.
* Basic knowledge of applicable regional/national country regulatory guidelines and EC regulations.
If you are interested in finding out more about this role or others, please contact Sharleney Chandraratna at schandraratna@i-pharmconsulting.com or call: +44 (0) 2075510732