FSP Country Approval Specialist
Thermo Fisher Scientific Inc
Country Approval Specialist
Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years. As part of our global team, you'll have the opportunity to participate in the management and preparation, review, and coordination of Country Submissions in line with the global submission strategy. As a Country Approval Specialist, you'll play a key role in ensuring that submissions are managed effectively and align with our strategic goals.
What You'll Do:
- Prepares, reviews and coordinates, under guidance, 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.
- Provides, under guidance local regulatory strategy advice (MoH &/or EC) to internal clients.
- Provides project specific local SIA services and coordination of these projects.
- May have contact with investigators for submission related activities.
- Key-contact at country level for either Ethical or Regulatory submission-related activities.
- Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.
- Achieves PPD's target cycle times for site.
- May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
- May develop country specific Patient Information Sheet/Informed Consent form documents.
- May assist with grant budgets(s) and payment schedules negotiations with sites.
- Supports the coordination of feasibility activities, as required, in accordance with agreed timelines.
- Enters and maintains trial status information relating to SIA activities onto PPD tracking databases in an accurate and timely manner.
- Ensures the local country study files and filing processes are prepared, set up and maintained as per PPD WPDs or applicable client SOPs.
- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Education and Experience Requirements:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
- Previous Contract Research Organization (CRO) experience is highly preferred.
- 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.
Knowledge, Skills and 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
- Basic medical/therapeutic area and medical terminology knowledge
- Ability to work in a team environment or independently, under direction, as required
- Basic organizational and planning skills
- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations
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.
- ...DESCRIPTION Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Country Approval Specialist – Make an Impact at the Forefront of Innovation! We have successfully supported the top 50 pharmaceutical companies and...SuggestedRemote jobFull timeWork at officeLocal area
- ...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...SuggestedRemote jobFull timeContract workWork at officeLocal area
- ...looking to fill a Scientist II or III - Metrology Specialist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our... ...procedures (SOPs) Responsibilities Prepare, review, and approve instrument/equipment documentation such as...SuggestedFull time
- ...Pre-Approval Specialist CrossCountry Mortgage (CCM) is the nation's number one distributed retail mortgage lender with more than 9,000 employees operating over 700 branches and servicing loans across all 50 states, D.C. and Puerto Rico. Our company has been recognized...SuggestedContract workTemporary work
$100k - $118k
Overview Fortrea's FSP Team is hiring a TMF Lead II! Remote US. Seeking strong experience... ...process, control, coordination, and approval of clinical trial documents. The position... ...metrics and analyzing trends across studies, countries and sites. Accountable for the creation...SuggestedFull timePart timeWork at officeRemote workFlexible hours$86.8k - $165.2k
...United States of AmericaTime Type: Full timeDate Posted:2026-09-08 Country:United States of America Location:US-CT-EAST HARTFORD-ETC ~ 40... ...and compile compliant Earned Value or project plan data approved by the program manager and provide to the external customer.Support...Contract workTemporary workWork experience placementWork at officeRemote workFlexible hours- A healthcare facility is seeking a Prior Authorization Specialist in Eugene, Oregon. This role involves managing insurance approvals for medical and ancillary services while ensuring accurate submissions of clinical documentation. The ideal candidate will have 2 to 5 years...
- ...Systems LLC in Mokena, IL is seeking a detail-oriented Permit Specialist to manage residential construction permits and documentation.... ...municipalities, and internal teams to ensure timely submissions and approvals. The role requires strong organization, clear communication,...Hourly pay
- ...limited partnership operating across 32 countries and territories in North America, the Greater... ...and oversight of the projects when approved. Manages new business economic approval... ...commensurate with the selected job level:The Specialist/Analyst level requires a Bachelor’s...Contract workWork experience placementWork at officeFlexible hoursNight shiftWeekend workAfternoon shift
- ...and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical... ...All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses...Work experience placementInternshipPlacement yearImmediate startRemote workFlexible hours
$60k - $65k
...life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical... ...PowerPoint and Outlook. Responsibilities: • Review and approve vendor-executed calibration, maintenance, repair, and performance...Remote jobHourly payFull timeTemporary workWork experience placementWork at officeImmediate start- ...currently seeking a Cntrcts. Negotiation Sr.Specialist Advsr to join our team in Plano, Texas (... ...risk profile against global contracts approval matrix.Requirements: Minimum of 10 years... ..., we have experts in more than 50 countries. We also offer clients access to a robust...Contract workWork at officeRemote workFlexible hours
- ...000 employees work across more than 150 countries to put patients first — developing innovative... .... Join Medtronic as an EP Mapping Specialist and be at the forefront of transforming... ...Medtronic recruiting communications come from approved Medtronic platforms and official @...Full timeWork experience placementH1bWork at officeLocal areaImmediate startRemote workWorldwideFlexible hoursNight shift
$66.3k - $67k
...We are seeking dedicated and compassionate Incident Management Specialist, who will play a critical role in making a positive impact on... ...regulations. Applicants for this position must be an OPWDD approved investigator with at least two years of experience conducting...Work experience placementWork at officeLocal area$96k - $118k
...employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise®... ...Position Summary The QAO Chemistry Specialist II provides Quality Assurance oversight... ...and regulatory compliance. Review and approve analytical data, laboratory documentation...Work at officeRelocationShift work- ...policies and Accounts Payable procedures. Tracks company car and country club usage. ESSENTIAL REQUIREMENTS Receives, reviews,... ...application for payment. Follows up on invoices that are not properly approved, properly documented, or are not in compliance with corporate...Full time
$53.52k - $96.74k
...YouTube . Job Description The Sr. Specialist, New Product Launch is an individual contributor... .... Leads playbook kickoff for each approved launch, following business case and... ...pay transparency laws enacted across the country, the expected salary range for this position...Full timeWork at officeFlexible hours$73k - $98k
Senior Associate, Operational Mapping Specialist LA28 does not provide relocation assistance... ...that celebrate all that this city and country have to offer, delivering an unparalleled... ...operational maps. Establish formal sign-off and approval procedures with venue and departmental...Temporary workWork experience placementSummer workWork at officeRelocation packageFlexible hours$92k - $171k
...expertise in NDE practices. The NDE Level III Specialist provides oversight of NDE activities,... ...engineering and design useReview and approve NDE procedures (RT, UT, PT, MT) for code... ...projectMust be authorized to work in the country where the position is locatedPreferred...Contract workFor contractors- ...Cybersecurity Assessment and Oversight Specialist [DOE0129128] for Program Support on a Exempt... ...across the Pacific Northwest Region (Of Country/World).Safeguards and security services... ...with the technical point of contact and approved in writing by the CO in advance is...Full timeContract workTemporary workFor contractorsFor subcontractorWork at officeRemote workFlexible hours
- ...DescriptionProSidian Seeks a Configuration Management Specialist | Compliance / Risk / Regulatory: Risk,... ...at project sites nationwide. Region (Of Country/World) Remote (within USA - W/ On-Site... ...control and verifying compliance with approved design baselines and change management...Full timeContract workTemporary workFor contractorsWork at officeRemote workFlexible hours
- ...team of 2,600 people across more than 20 countries, but, it is above all about playing a... ...YoutubeWHAT WE ARE LOOKING FORThe QC Sampling Specialist will operate in full compliance with... ...regulated environment, ensuring compliance with approved procedures, aseptic techniques, and...Local area
$86.7k - $173.3k
...Our 122,000 colleagues serve people in more than 160 countries.JOB DESCRIPTION:Senior Specialist, Global Raw Material Planning About AbbottAbbott is a... ...constrained supply situations based on business priorities and approved allocation rules.Monitor supplier commitments and...Local areaShift work$60 per hour
...leaders in the field. The Per Diem Diagnostic Specialist (Ultrasound/Micro-Ultrasound) performs... ....QualificationsGraduate of an AMA approved radiography program1 year minimum of experience... ...Kravis Children's Hospital among the country’s best in several pediatric specialties....Hourly payDaily paidTraineeshipLocal area- ...history, and benchmarking toolsPrepare sourcing recommendations for approval by the Director TP or Sourcing CommitteeUpon approval, notify... ..., and support cost reduction initiatives (including low-cost country sourcing)Manage supplier performance through capacity planning,...
- ...a Oversight and Continuous Improvement Specialist [DOE0096095] for Program Support on a Exempt... ...across the Pacific Northwest Region (Of Country/World).Safety, environment, and quality... ...with the technical point of contact and approved in writing by the CO in advance is...Full timeContract workTemporary workFor contractorsFor subcontractorWork at officeRemote workFlexible hours
$86.8k - $165.2k
...Type: Full timeDate Posted:2026-08-31 Country:United States of America Location:US-AL... ...highly skilled and motivated Principal Specialist, Contracts to support our Global PATRIOT... ...staffing of acquisition packages to required approval authoritiesSign contractual documents on...Contract workTemporary workWork experience placementWork at officeRemote workFlexible hours- ...employees across 33 manufacturing sites in 12 countries we serve over 90% of the world’s... ...SummaryWe’re hiring an Industrialization Specialist to ensure on‑time delivery of new facilities... ...documents and monitor through to approval, implementation, and post project evaluation...Contract workTemporary workFor contractorsFor subcontractor
$96.8k - $130k
...consumer products company operating in over 200 countries specializing in Oral Care, Personal Care,... ..., healthier future for all.As a Raw Material Specialist, you will oversee and manage global material qualification, approval, and compliance initiatives in close collaboration...Hourly payLocal areaRelocation- ...Seeks a DNFSB Interface and Coordination Specialist [DOE0107106] for Program Support on a... ...across the Pacific Northwest Region (Of Country/World).Safety, environment, and quality... ...with the technical point of contact and approved in writing by the CO in advance is allowed...Full timeContract workTemporary workFor contractorsFor subcontractorWork at officeRemote workFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to FSP Country Approval Specialist. Be the first to apply!
- loss prevention specialist United States
- fixed income specialist United States
- docketing specialist United States
- total rewards specialist United States
- settlement specialist United States
- inclusion specialist United States
- accessibility specialist United States
- hearing aid specialist United States
- orientation and mobility specialist United States
- skin specialist United States





