[Skip to main content](#main-content) [OpenNash Jobs](https://jobs.opennash.com/) [Hiring report](/reports/hiring/) · [All Thermo Fisher Scientific jobs](https://jobs.opennash.com/companies/thermo-fisher-scientific/) · [Search jobs](/search/) Thermo Fisher Scientific # Senior/Principal - Country Approval Specialist Remote, North Carolina, United States of America Remote Full-time Senior individual contributor Healthcare & Clinical Listed on Thermo Fisher Scientific’s official careers site. Posted July 21, 2026. Check that it is still open and apply there. [Apply on Thermo Fisher Scientific’s careers site →](https://jobs.thermofisher.com/global/en/job/TFSCGLOBALR01360660EXTERNALENGLOBAL/Senior-Principal-Country-Approval-Specialist) [OpenNash Jobs](https://jobs.opennash.com/) / [Thermo Fisher Scientific](https://jobs.opennash.com/companies/thermo-fisher-scientific/) / Senior/Principal - Country Approval Specialist ## Job description Work Schedule Standard (Mon-Fri) Environmental Conditions Office ### Job Description Join Us as a Senior/Principal Country Approval Specialist - Make an Impact at the Forefront of Innovation The Senior/Principal Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission strategy. ### What You'll Do - Prepare, review and coordinate local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) 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 SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy. - Develop country specific Patient Information Sheet/Informed Consent form documents. - May assist with grant budgets(s) and payment schedules negotiations with sites. - Assist in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions. - Support the coordination of feasibility activities, as required, in accordance with agreed timelines. - Ensure that trial status information relating to SIA activities are accurately maintained in the database and is current at all times. - Oversee country study files and ensure that that they meet PPD WPD’s or client SOP’s. - Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided. - Direct/mento other SIA individuals assigned to support projects of responsibility, as appropriate - Proactively identify issues or anomalies in the regulatory process of a study, resolve or escalate as appropriate. ### Education & Experience Requirements: For Senior Country Approval Specialist: - Bachelor's degree or equivalent and relevant formal academic / vocational qualification - Previous experience that provides the knowledge, skills, and abilities to perform the job (2+ years direct startup experience in CRO/Sponsor setting or comparable to 5+ years relevant experience). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. ### For Principal Country Approval Specialist - Previous experience that provides the knowledge, skills, and abilities to perform the job (5+ years direct startup experience in CRO/Sponsor setting or comparable to 8+ years relevant experience). ### Knowledge, Skills, Abilities - Effective oral and written communication skills - Excellent interpersonal skills - Strong attention to detail and quality of documentation - Good negotiation skills - Good computer skills and the ability to learn appropriate software - Good English language and grammar skills - Good judgment and decision-making skills - Basic medical/therapeutic area and medical terminology knowledge - Ability to work in a team environment or independently, with minimal supervision, as required - Ability to mentor fellow SIA team members in a positive and effective manner - Excellent team player with teambuilding skills - Basic organizational and planning skills - Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference. Apply today to help us deliver tomorrow’s breakthroughs. ## At a glance - Posted by the employer: Jul 21, 2026 - First seen by OpenNash: Aug 20, 2026 - Last checked: Oct 20, 2026 - Listed for: 91 days - Location: Remote, North Carolina, United States of America - Work arrangement: Remote - Employment type: Full-time[Apply on Thermo Fisher Scientific’s careers site →](https://jobs.thermofisher.com/global/en/job/TFSCGLOBALR01360660EXTERNALENGLOBAL/Senior-Principal-Country-Approval-Specialist) ## More jobs at Thermo Fisher Scientific ### [Clinical Program Quality Excellence Lead - FSP Team](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/62e029b0a1fcd06b040b/) Remote, North Carolina, United States of America ### [DO NOT APPLY - TEST REQ - CRG - Med Information Nurse I - Morrisville US](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/741f6fa04c9b265fecee/) Remote, North Carolina, United States of America ### [DO NOT APPLY - TEST REQ - Trial Activation Contract Specialist I - Morrisville US](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/ec01020382308564c237/) Remote, North Carolina, United States of America ### [FSP Associate Contract Specialist/Contract Specialist](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/518ab83a2084f259fdd5/) Remote, North Carolina, United States of America ### [FSP Clinical Trial Coordinator](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/9a888a1d17afb5ceb648/) Remote, North Carolina, United States of America ## Similar jobs at other companies ### [Relationship Banker - Canyon Country - Canyon Country, CA](https://jobs.opennash.com/companies/jpmorganchase/jobs/de98f0f2f63da4c550cd/) JPMorganChase · Canyon Country, CA, United States ### [Sales Associate Country Club Plaza](https://jobs.opennash.com/companies/essilorluxottica/jobs/a1b319592cab0eeaff61/) EssilorLuxottica · Kansas City, MO, US ### [store manager, Hill Country](https://jobs.opennash.com/companies/starbucks/jobs/54db2a66eb0f9eef5ba8/) Starbucks · San Antonio, Texas, United States ### [Country Risk Management - Business Manager, Vice President](https://jobs.opennash.com/companies/jpmorganchase/jobs/65e0de7769a43a154486/) JPMorganChase · NY, United States ### [EVS Worker - BSWH Hill Country Clinics](https://jobs.opennash.com/companies/aramark/jobs/ef4dd47b78aa1d8055d3/) Aramark · Marble Falls, TX, US OpenNash lists jobs from employers’ own careers sites and does not handle applications. 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