Sr. Country Approval Specialist / Principal Country Approval Specialist

New

United StatesFull-TimeSenior

Salary not disclosed

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Job Details

Languages: English
Experience: 2-5+ years

Requirements

Bachelor's degree or equivalent academic/vocational qualification.
2-5+ years of relevant professional experience.
Effective oral and written communication skills.
Excellent interpersonal skills.
Strong attention to detail.
Good negotiation skills.
Computer proficiency and ability to learn internal systems.
Good English language and grammar skills.
Basic knowledge of medical/therapeutic area and terminology.
Ability to work independently and in a team environment.
Excellent knowledge of regional/national regulatory guidelines and EC regulations.

Responsibilities

Prepare, review and coordinate local regulatory submissions including MoH, EC, and import licenses.
Provide local regulatory strategy advice to internal clients.
Serve as primary contact for investigators and local regulatory authorities.
Coordinate with internal functional departments to align site start-up and submission activities.
Ensure site activation cycle times are achieved.
Develop country-specific Patient Information Sheet and Informed Consent forms.
Maintain trial status information in databases.
Oversee country study files to ensure compliance with SOPs.
Mentor other SIA individuals assigned to projects.
Identify and escalate issues or anomalies in the regulatory process.

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