FSP Country Approval Specialist

Lifelancer is a talent-hiring platform serving the life sciences, pharmaceutical, and IT sectors. The FSP Country Approval Specialist supports the preparation, review, coordination, and management of local regulatory and ethics submissions for clinical trials. The role also coordinates site start-up activities, maintains study documentation and tracking databases, and provides country-level submission support.

Responsibilities

Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy

Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients

Provides project specific local SIA services and coordination of these projects

May have contact with investigators for submission related activities

Key-contact at country level for either Ethical or Regulatory submission-related activities

Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation

Achieves PPD’s target cycle times for site

May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable

May develop country specific Patient Information Sheet/Informed Consent form documents

May assist with grant budgets(s) and payment schedules negotiations with sites

Supports the coordination of feasibility activities, as required, in accordance with agreed timelines

Entes and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner

Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs

Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided

Benefits

Remote work arrangement

Company

AI-powered talent hiring platform for life sciences, pharma, and IT

London, England, GBR

https://lifelancer.com/

Founded in 2020

11-50 employees

Qualifications

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)

Effective oral and written communication skills

Excellent interpersonal skills

Strong attention to detail and quality of documentation

Good negotiation skills

Good computer skills and the ability to learn appropriate software

Good English language and grammar skills

Basic medical/therapeutic area and medical terminology knowledge

Ability to work in a team environment or independently, under direction, as required

Basic organizational and planning skills

Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

Required skills

Clinical Trial Regulatory Submissions, Regional and National Regulatory Guidelines, Ethics Committee Regulations, Medical Terminology

Experience

2+ years