Country Approval Specialist - Client-dedicated
Welcome to Thermo Fisher Scientific - the world leader in serving science! We are currently seeking a highly motivated and detail-oriented individual to join our team as a Country Approval Specialist - Client-dedicated. As a member of our global organization, you will have the opportunity to work with cutting-edge technology and make a meaningful impact on the healthcare industry. In this role, you will be responsible for ensuring the timely and accurate approval of our products in designated countries, working closely with our clients to meet their unique needs. If you are a self-starter with excellent communication skills and a passion for delivering exceptional customer service, we want to hear from you! Read on to learn more about the qualifications and requirements for this exciting opportunity.
- Collaborate with clients to understand their specific needs and requirements for product approvals in designated countries.
- Conduct thorough research and analysis of local regulations and requirements for product approvals.
- Develop and maintain strong relationships with regulatory authorities in designated countries.
- Prepare and submit necessary documentation for product approvals, ensuring compliance with all regulatory standards.
- Monitor and track the progress of product approvals, providing regular updates to clients.
- Proactively identify potential regulatory roadblocks and develop solutions to ensure timely approval of products.
- Communicate effectively with internal teams and clients to gather necessary information and address any issues or concerns.
- Maintain accurate and up-to-date records of all product approval activities.
- Adhere to company policies and procedures, as well as regulatory guidelines, in all product approval processes.
- Continuously monitor and evaluate the effectiveness of product approval processes, identifying areas for improvement.
- Stay updated on industry trends and changes in regulatory requirements to ensure compliance.
- Provide exceptional customer service to clients, promptly addressing any inquiries or concerns related to product approvals.
- Collaborate with cross-functional teams to ensure smooth and efficient product approval processes.
- Assist with training and mentoring new team members, as needed.
- Handle any other duties or projects assigned by the supervisor.
Expert Knowledge Of Country-Specific Regulations And Approval Processes: A Country Approval Specialist Must Possess A Thorough Understanding Of The Regulatory Requirements And Approval Processes For The Specific Country They Are Responsible For. This Includes Knowledge Of Submission Requirements, Timelines, And Potential Roadblocks In The Approval Process.
Strong Communication And Project Management Skills: As A Client-Dedicated Specialist, The Individual Must Effectively Communicate With Both Internal And External Stakeholders To Ensure Timely And Successful Approvals. This Requires Excellent Project Management Skills To Coordinate And Prioritize Tasks And Ensure All Parties Are Kept Informed.
Experience With Regulatory Submissions And Dossier Preparation: The Role Of A Country Approval Specialist Involves Compiling And Submitting Regulatory Dossiers For Product Approval. Therefore, A Strong Understanding Of The Dossier Preparation Process And Experience With Regulatory Submissions Is Essential.
Attention To Detail And Organization: The Approval Process For New Products Or Changes To Existing Products Can Be Complex And Involve Multiple Documents And Stakeholders. A Country Approval Specialist Must Have A High Level Of Attention To Detail And Be Highly Organized To Ensure All Necessary Information Is Accurately Compiled And Submitted.
Ability To Adapt To Changing Regulations And Requirements: Regulatory Requirements And Processes Are Constantly Evolving, And A Country Approval Specialist Must Be Able To Adapt Quickly And Effectively. This May Involve Staying Updated On Regulatory Changes, Adjusting Submission Strategies, And Finding Alternative Solutions To Overcome Roadblocks In The Approval Process.
Quality Assurance
Project Management
Data Analysis
Time Management
Technical
Risk assessment
Regulatory compliance
Team collaboration
Problem-Solving
Client communication
Documentation management
Country Regulations
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Active Listening
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Country Approval Specialist - Client-dedicated in Poland is between 9,000 PLN to 14,000 PLN per month. This equates to approximately $2,400 to $3,700 USD per month. However, salaries may vary depending on the specific company, location, and level of experience.
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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.
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