Thermo Fisher Scientific

Sr Ctry Approval Spec

Thermo Fisher Scientific

Remote
Full-TimeDepends on ExperienceMid-LevelBachelors
Job Description

Are you looking for a challenging and dynamic role in the scientific industry? Thermo Fisher Scientific is seeking a highly motivated Senior Country Approval Specialist to join our team. As a global leader in providing innovative solutions, we are looking for a talented individual with a strong background in regulatory affairs and a passion for driving results. If you possess excellent communication skills, attention to detail, and the ability to work in a fast-paced environment, we want to hear from you! Join us in our mission to enable our customers to make the world healthier, cleaner, and safer.

  1. Review and ensure compliance of all regulatory requirements for product approvals in assigned country/region.
  2. Collaborate with cross-functional teams to develop and maintain regulatory strategies and plans.
  3. Prepare and submit product registration dossiers and other necessary documents to regulatory agencies.
  4. Monitor and track the status of ongoing product approvals and updates, ensuring timely completion.
  5. Communicate and negotiate with regulatory agencies to resolve any issues or concerns related to product approvals.
  6. Stay updated on relevant regulations and guidelines in the assigned country/region and provide guidance to the company on any changes or updates.
  7. Act as a point of contact for internal and external stakeholders regarding regulatory affairs in the assigned country/region.
  8. Ensure timely and accurate reporting of regulatory activities and maintain appropriate documentation.
  9. Provide support and guidance to junior team members, as needed.
  10. Contribute to process improvement initiatives to optimize efficiency and effectiveness of regulatory processes.
  11. Represent the company in meetings and conferences related to regulatory affairs.
  12. Maintain a strong understanding of the company's products and their intended use to support regulatory submissions and approvals.
  13. Ensure compliance with company policies and procedures related to regulatory affairs.
  14. Collaborate with global regulatory teams to ensure consistency and alignment in regulatory strategies and submissions.
  15. Continuously seek opportunities to improve and streamline regulatory processes and procedures.
Where is this job?
This job opening is listed as 100% remote
Job Qualifications
  • Minimum Of 5 Years Of Experience In Country Or Regional Regulatory Affairs, Preferably In The Life Sciences Or Healthcare Industry.

  • Bachelor's Degree In A Scientific Or Healthcare-Related Field, Such As Biology, Chemistry, Or Pharmacy.

  • In-Depth Knowledge Of Local And International Regulations And Guidelines For Product Registration And Approval.

  • Strong Understanding Of The Drug Development Process And Experience With Regulatory Submissions And Approvals.

  • Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams And Regulatory Authorities.

Required Skills
  • Quality Assurance

  • Communication Skills

  • Project Management

  • Time Management

  • Leadership

  • Analytical Thinking

  • Risk assessment

  • Teamwork

  • Regulatory compliance

  • Problem-Solving

  • Attention to

  • Documentation management

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • creativity

  • Teamwork

  • Active Listening

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Sr Ctry Approval Spec is $65,000-$85,000 per year. The salary may vary depending on the specific company, location, and level of experience. Additional factors such as bonuses, benefits, and company size may also affect the salary range.

Additional Information
Thermo Fisher Scientific is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesEnglish
Job PostedMarch 19th, 2025
Apply BeforeJune 21st, 2025
This job posting is from a verified source. 

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About Thermo Fisher Scientific

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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