Country Approval Specialist IIIII

Work Schedule

Environmental Conditions

Job Description

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs spanning 2700 clinical trials across 100 countries in the last 5 years.

As part of our global team you will play a key role in the management preparation review and coordination of Country Submissions in alignment with the global submission addition you will support critical study start-up activities including coordination with sites on agreements and budgets to ensure timely site activation. As a Country Approval Specialist you will ensure submissions and start-up activities are executed efficiently and aligned with both regulatory requirements and study timelines.

What Youll Do:
Prepares reviews and coordinates under guidance local regulatory submissions (MoH EC and other applicable national requirements) in alignment with global submission strategy
Provides under guidance local regulatory strategy advice (MoH and/or EC) to internal stakeholders
Acts as a key country-level contact for ethical and regulatory submission-related activities
Coordinates with internal functional departments to align submission activities with site start-up timelines and study milestones
Supports site start-up activities including coordination of site agreements budgets and payment schedules to facilitate timely site activation
Assists in reviewing and coordinating site contract and budget-related documents working closely with internal stakeholders and sites
May engage with investigators and site personnel for submission and start-up related activities
Supports feasibility activities and ensures alignment with study timelines
Ensures accurate and timely entry and maintenance of study information in tracking systems
Prepares maintains and ensures compliance of local study files in accordance with SOPs and client requirements
Maintains up-to-date knowledge of applicable SOPs regulatory requirements and guidelines


Education and Experience Requirements:
Bachelors degree or equivalent in a relevant field
Minimum 3 years of experience in clinical research regulatory or study start-up roles
Experience supporting site start-up activities including site agreement and budget coordination is preferred
Equivalent combination of education training and experience will be considered .

Knowledge Skills and Abilities:
Effective oral and written communication skills
Excellent interpersonal and stakeholder management skills
Strong attention to detail and quality of documentation
Good negotiation skills particularly in supporting site agreements and budget discussions
Basic understanding of clinical trial start-up processes including regulatory submissions and site activation activities
Ability to coordinate across multiple stakeholders and timelines
Good computer skills and ability to learn relevant systems
Good English language and grammar skills
Basic knowledge of medical terminology and therapeutic areas
Ability to work independently and within a team environment
Basic knowledge of applicable regional and local regulatory requirements

Working Conditions and Environment:

Work is performed in a flexible (hybrid) environment with occasional on-site presence at the clients office may be needed.