This job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly. Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Country Approval Associate - Make an Impact at the Forefront of Innovation The Country Approval Associate supports the preparation, review and coordination of Country Submissions in line with global submission strategy. What You'll Do: • Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission strategy. • Support preparation, under guidance, of local MoH submissions, as applicable in • alignment with global submission strategy. • Coordinate, under guidance, 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. • May have contact with investigators for submission related activities. • May act as a key-contact at country level for either Ethical or Regulatory submission-related activities. • Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable. • Assist in developing country specific Patient Information Sheet/Informed Consent form documents. • Assist with grant budgets(s) and payment schedules negotiations with sites. • Enter and maintain trial status information relating to SIA activities onto company, or client (where contracted) tracking databases in an accurate and timely manner • Ensure the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs. • Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as

📌 Country Approval Specialist (India)
🏢 Thermo Fisher Scientific
📍 India