Country Approval Specialist
No salary listed
Junior
Bachelor's
Remote in China
Remote
Biology & BiotechClinical Research Operations
About the job
Requirements
- A bachelor's degree or equivalent and a relevant formal academic or vocational qualification.
- Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 2 years; an equivalent combination of appropriate education, training, and/or directly related experience may suffice.
- Effective oral and written communication skills and good English language and grammar skills.
- Strong attention to detail and quality of documentation.
- Good negotiation and computer skills, with the ability to learn appropriate software.
- Basic medical/therapeutic area knowledge 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 applicable regional and national country regulatory guidelines and Ethics Committee regulations.
- Ability to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Ability to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Ability to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Responsibilities
- Prepare, review, and coordinate local regulatory submissions under guidance, including Ministry of Health and Ethics Committee submissions and applicable special national/local applications such as gene therapy approvals, viral safety dossiers, and import licenses, in alignment with the global submission strategy.
- Provide local regulatory strategy advice for Ministry of Health and/or Ethics Committee submissions to internal clients under guidance.
- Provide and coordinate project-specific local study startup services.
- Contact investigators regarding submission-related activities as needed.
- Serve as the country-level key contact for ethical or regulatory submission-related activities.
- Coordinate with internal functional departments under guidance to align site startup activities with submissions activities and mutually agreed timelines, ensuring submission processes for sites and studies align with the critical path for site activation.
- Achieve the company's target site cycle times.
- Develop country-specific Patient Information Sheet/Informed Consent Form documents as needed.
- Assist with grant budgets and payment schedule negotiations with sites as needed.
- Support coordination of feasibility activities in accordance with agreed timelines as required.
- Enter and maintain trial status information related to startup activities in company tracking databases accurately and promptly.
- Prepare, set up, and maintain local country study files and filing processes according to company WPDs or applicable client standard operating procedures.
- Maintain knowledge of and understand company and client standard operating procedures/directives and current regulatory guidelines applicable to the services provided.
- Travel as required; details will be provided by the recruiter.
About the company
Thermo Fisher Scientific makes and sells the instruments, chemicals, consumables and lab services that drug companies, hospitals, universities and industrial labs use for research, testing and production. Its products cover work from gene sequencing and protein analysis to diagnostic tests and lab freezers, and its distribution arm ships supplies to labs worldwide. Drug developers also hire it to run clinical trials and to manufacture medicines under contract. It earns money from consumables that labs buy again and again, along with instrument sales, service contracts and outsourcing fees. The company traces its roots to Thermo Electron, founded in 1956, which merged with Fisher Scientific in 2006, and it is based in Waltham, Massachusetts.
Company Size
10,001+
Company Stage
IPO
Headquarters
Waltham, Massachusetts
Founded
1956
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Simplify's Take
What believers are saying
- Drugmaker demand is firming: revenue rose 10% to $11.99 billion in the June 2026 quarter, 5% excluding deals and currency.
- Profits are outpacing sales, which supports stock grants: adjusted earnings per share rose 13% in the June 2026 quarter.
- Career paths span many businesses: Thermo Fisher runs four segments, from diagnostics to contract drug development.
What critics are saying
- Factory jobs are shrinking: Thermo Fisher announced in January 2026 it will close its Asheville plant, cutting 421 jobs.
- Whole units get sold: microbiology, with $645 million in 2025 sales, went to buyout firm Astorg in August 2026.
- Cuts reach California too: Thermo Fisher filed in January 2026 to lay off 173 Carlsbad workers by March.
What makes Thermo Fisher Scientific unique
- Many familiar lab brands sit under one roof: Thermo Fisher owns Thermo Scientific, Applied Biosystems, Invitrogen and Fisher Scientific.
- Thermo Fisher reaches labs through its own sales force of about 14,000 people, per its 2025 annual filing.
- Its trial-data unit Clario has supported about 70% of FDA and EMA novel drug approvals over the past decade.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Unlimited Paid Time Off
- Paid Vacation
- Paid Sick Leave
- Paid Holidays
- Hybrid Work Options
- 401(k) Retirement Plan
- 401(k) Company Match