Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Join Us as a Senior Country Approval Specialist - Make an Impact at the
Forefront of Innovation
The Senior Country Approval Specialist manages the preparation, review and
coordination of Country Submissions in line with integral submission strategy.

What You'll Do:
• Prepare, review and coordinate local regulatory submissions (MoH, EC,
additional special national local applications if applicable in alignment with
global submission strategy.
• Provide local regulatory strategy advice (MoH &/or EC) to internal clients.
• Develop and implement local submission strategy. Provide technical expertise
and coordination oversight for projects in collaboration with relevant internal
departments.
• Serve as primary contact for investigators and with the local regulatory
authorities (in collaboration with the local regulatory manager for complex
issues) to ensure submissions are managed in a timely manner.
• Ensure guidelines and processes are followed for effective internal team




communications as well as communications with investigators, and with the
country regulatory authorities to ensure submissions are managed in a timely
manner.
• Act as a key-contact at country level for all submission-related activities.
• Participate as required in Submission Team Meetings, Review Meetings and
Project Team meetings.
• Coordinate with internal functional departments to ensure various site
start-up activities are aligned with submissions activities and mutually agreed
upon timelines; ensure alignment of submission process for sites and study are
aligned to the critical path for site activation.
• Achieve company’s target cycle times for site activations.
• Prepare the regulatory compliance review packages, as applicable.
• Liaise within SSU team locally to ensure local submission activity is planned
and delivered in accordance with global project submission strategy.
• Develop country specific Patient I

📌 Sr Ctry Approval Spec (Buenos Aires)
🏢 Thermo Fisher Scientific
📍 Buenos Aires