EXPLORE

Careers at ThermoFisher Scientific

Apply Now >>    
Job ID :
66514BR
Location :
Japan - Tokyo
:
Job Description

Regulatory affairs specialist focuses on ensuring organizations are meeting all of the applicable regulations, such as those established by the Ministry of Health, Labor and Welfare, local governments, and such a regulatory authority as PMDA; Pharmaceuticals and Medical Devices Agency, for our products and services. These specialists do so by completing and filing paperwork with the appropriate local agencies. Regulatory affairs specialists usually work full-time, or part-time, in both at Yokohama and Mita according to business requirements.

Responsibilities:

  • Coordinate and participate in preparation of different types of regulatory submissions (e.g. dossier, variations, scientific advice submissions, etc.) to competent authorities for approved and developmental products
  • Develop content, timelines and contingencies for submissions in collaboration with internal and external contributors
  • Ensure that submissions are of high quality, meet all regulatory requirements and are in compliance with corporate goals and directives
  • Provide regulatory feedback in project teams
  • Participate in contacting competent authorities for respective projects/products and interact with internal departments
  • General regulatory and maintenance tasks
  • Creating internal QMS structure and implementing QMS guidelines in accordance to the QMS Ordinance

Experience / Other Requirements:

  • Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance
  • Ability to develop innovative strategies and creative solutions within the regulatory context within the scope of global requirements and available resources
  • Strong initiation and organizational skills
  • Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes
  • Strong analytical skill and technical/ scientific competence
  • Attention to details and ability to appropriately assess risks and formulate risk-management strategies, including taking “the big picture” view on various options
  • Team-player, able to positively influence team members at all levels with an entrepreneurial “can do” attitude
  • Proactive, quick learner and independent worker able to effectively multi-task in a high pressure environment and follow issues through to conclusion
  • Experience from working with medical device or I2-3 years’ experience in quality function in the pharmaceutical industry
  • Business level written and oral skill is required

Educational Qualification

  • Bachelor degree in pharmaceutical science and/or regulatory affairs
  • Licensed pharmacist is an advantage


Apply Now >>    
Link for schema
Join our Talent Community

If you're ready to make a difference in the world, you can do it here.

Join

SHARE

5 Reasons to Work at Thermo Fisher Scientific
View
Search Jobs by Map
Search