Country Approval Specialist - FSP dedicated - EMEA
Are you passionate about ensuring compliance with country-specific regulations and approvals for scientific products? Do you have experience working in a fast-paced, global environment? Thermo Fisher Scientific is seeking a dedicated and detail-oriented Country Approval Specialist to join our team in EMEA. As an integral member of our FSP (Functional Service Provider) division, you will play a crucial role in driving the success of our products in the market. This is an exciting opportunity for a highly organized and proactive individual with a strong understanding of international regulatory requirements.
- Ensure compliance with country-specific regulations: The Country Approval Specialist will be responsible for staying up-to-date with all relevant regulations and ensuring that all scientific products meet the necessary requirements for each country in the EMEA region.
- Obtain necessary approvals: This role will involve obtaining all necessary approvals and certifications for scientific products to be sold in the EMEA region. This will require a thorough understanding of the approval process and strong communication and negotiation skills.
- Work in a fast-paced global environment: The Country Approval Specialist will be expected to work efficiently and effectively in a fast-paced, global environment. This will involve managing multiple projects and deadlines simultaneously and adapting to changing regulations and requirements.
- Collaborate with cross-functional teams: The successful candidate will work closely with cross-functional teams, including regulatory affairs, quality assurance, and product development, to ensure that all necessary approvals are obtained and maintained.
- Conduct thorough research: The Country Approval Specialist will be responsible for conducting thorough research to understand the specific regulations and requirements for each country in the EMEA region. This will involve keeping up-to-date with any changes or updates to regulations.
- Maintain accurate documentation: Accurate and organized documentation is essential for compliance with regulatory requirements. The Country Approval Specialist will be responsible for maintaining detailed records of all approvals and certifications obtained.
- Proactively identify potential issues: The role will involve proactively identifying any potential issues or roadblocks in the approval process and finding solutions to overcome them. This will require strong problem-solving skills and attention to detail.
- Support the success of products in the market: As an integral member of the team, the Country Approval Specialist will have a crucial role in supporting the success of products in the market by ensuring compliance with all necessary regulations and obtaining timely approvals.
- Stay informed about industry trends: The successful candidate will be responsible for staying informed about industry trends and changes in regulations, which may impact the approval process.
- Maintain confidentiality: The Country Approval Specialist will be
In-Depth Knowledge Of European Regulatory Requirements: A Country Approval Specialist At Thermo Fisher Scientific Should Possess A Thorough Understanding Of The Various Regulatory Requirements And Guidelines Governing Clinical Trials In The Emea Region. This Includes Knowledge Of The European Medicines Agency (Ema) Regulations, Good Clinical Practice (Gcp) Guidelines, And Other Relevant Laws And Regulations.
Extensive Experience In Fsp Clinical Trials: Thermo Fisher Scientific Is A Leading Provider Of Functional Service Provider (Fsp) Solutions, And The Ideal Candidate Should Have Extensive Experience In Managing Fsp Clinical Trials. This Includes Experience In Developing And Implementing Fsp Strategies, Managing Budgets, And Ensuring Compliance With Regulations.
Strong Project Management Skills: A Country Approval Specialist At Thermo Fisher Scientific Should Possess Excellent Project Management Skills To Effectively Plan, Organize, And Execute Clinical Trials In The Emea Region. This Includes The Ability To Set Timelines, Manage Resources, And Ensure Timely And Efficient Completion Of Tasks.
Excellent Communication And Interpersonal Skills: As A Country Approval Specialist, The Candidate Will Be Required To Liaise With Various Stakeholders, Including Regulatory Authorities, Study Teams, And Internal Departments. Therefore, Strong Communication And Interpersonal Skills Are Essential To Effectively Manage Relationships And Facilitate The Approval Process.
Attention To Detail And Problem-Solving Abilities: The Candidate Should Possess A Meticulous Approach To Work, With A Strong Attention To Detail To Ensure Accurate And Compliant Submissions To Regulatory Authorities. Additionally, The Ability To Identify And Solve Problems Is Crucial In Navigating The Complex Regulatory Landscape Of The Emea Region.
Quality Assurance
Project Management
Global regulations
Risk assessment
Document management
Regulatory compliance
Cross-Functional Collaboration
Clinical Trials
Protocol Review
Submission Management
Country-Specific Knowledge
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Country Approval Specialist - FSP dedicated - EMEA is between $60,000 and $90,000 USD per year. This can vary depending on factors such as location, experience, and specific job responsibilities. Additional benefits and bonuses may also be included in the compensation package.
Apply with Video Cover Letter Add a warm greeting to your application and stand out!
Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.
Get interviewed today!
JobzMall is the world‘ s largest video talent marketplace.It‘s ultrafast, fun, and human.
Get Started