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Regulatory Affairs Specialist II

AT Thermo Fisher Scientific
Thermo Fisher Scientific

Regulatory Affairs Specialist II

Remote

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

  • Acts as liaison with internal stakeholders in the provision of these services.
  • Works with the Regulatory Affairs Management to perform the day to day operational aspects of the Department such as: assessment of regulatory documents, preparation and assembly of global regulatory submissions, QC review of the final submission package.
  • Interfaces with PPD project teams and Health Authorities regarding regulatory strategy/submission activities.
  • Develops and maintains a cooperative working relationship with Project Managers and project team members for assigned projects.
  • Advises and directs project team as to their responsibilities relative to regulatory strategy/submission activities.
  • Acts as a key liaison between Regulatory Affairs Department and project team for assigned projects.

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Education and Experience:

  • Bachelor's Degree; degree in Pharmacy or Life Science is an advantage
  • Previous regulatory experience, or combination of higher education/less experience or substitution of equivalent relevant work experience will be considered

Job ID: ThermoFisher-R-01284251
Employment Type: Full Time

Perks and Benefits

  • Health and Wellness

    • Health Insurance
    • Dental Insurance
    • Vision Insurance
    • Life Insurance
    • Short-Term Disability
    • Long-Term Disability
    • FSA
    • HSA
    • HSA With Employer Contribution
    • Mental Health Benefits
    • Fitness Subsidies
  • Parental Benefits

    • Adoption Leave
    • Birth Parent or Maternity Leave
    • Non-Birth Parent or Paternity Leave
    • Fertility Benefits
    • Adoption Assistance Program
    • Family Support Resources
  • Work Flexibility

    • Flexible Work Hours
    • Hybrid Work Opportunities
    • Remote Work Opportunities
  • Office Life and Perks

    • Commuter Benefits Program
    • On-Site Cafeteria
  • Vacation and Time Off

    • Paid Vacation
    • Paid Holidays
    • Volunteer Time Off
  • Financial and Retirement

    • 401(K) With Company Matching
    • Stock Purchase Program
    • Financial Counseling
    • Performance Bonus
  • Professional Development

    • Tuition Reimbursement
    • Access to Online Courses
    • Internship Program
    • Mentor Program
  • Diversity and Inclusion

    • Employee Resource Groups (ERG)
    • Diversity, Equity, and Inclusion Program