Job Description

Position Overview

Prepares, reviews, and coordinates local regulatory submissions (MoH, EC and additional special national local applications if applicable) in alignment with the global submission strategy. Develops and implements the local submission strategy and provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments. Acts as a key contact at country level for all submission related activities and participates in Submission Team Meetings, Review Meetings and Project Team meetings as required.

Responsibilities

• Prepares, reviews, and coordinates local regulatory submissions (MoH, EC and additional special national local applications if applicable) in alignment with the global submission strategy.
• Develops and implements the local submission strategy.
• Provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.
• Acts as the primary contact for investigators and local regulatory authorities to ensure submissions are managed in a timely manner.
• Acts as a key contact at country level for all submission related activities.
• Participates in Submission Team Meetings, Review Meetings and Project Team meetings as required.
• Ensures the submission process for sites and studies are aligned to the critical path for site activation.
• Prepares Regulatory Compliance Review packages, as applicable.
• Liaises within SIA locally to ensure the local submission activity is planned and delivered in accordance with the global project submission strategy.
• Develops country and site-specific Patient Information Sheet/Informed Consent form documents.

Requirements

• Education: Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Experience: Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

Working Conditions and Environment

• Work is performed in an office/ laboratory and/or a clinical environment.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Exposure to electrical office equipment.
• Personal protective equipment required such as protective eyewear, garments and gloves.

Employment Details

• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Location Type: [Not Specified]
• Salary: [Not Specified]
• Environmental Conditions: Office