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Precision Medicine Group logo
Precision Medicine Group

Precision Medicine Group delivers specialty services that help its life science clients navigate healthcare challenges. The company entered its 10th year of suc

Regulatory Manager

Location

United States

Posted

121 days ago

Salary

$106K - $151K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglish

Job Description

Regulatory Manager

Precision Medicine Group

• Provides regulatory guidance throughout the clinical development life cycle • Compile, coordinate and review applications to Regulatory Authorities • Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees • Serve as representative of Global Regulatory Affairs at project team meetings • Works within a project team, and where necessary, leads project for the region or globally • Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets • Maintenance of project plans, project trackers and regulatory intelligence tools • Assist in development of Regulatory Affairs Specialists and other operational area staff • Provide input into regulatory strategy and timeline development for new study opportunities • Participates in maintaining and executing on the corporate quality initiatives across business units

Job Requirements

  • Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
  • Computer literacy (MS Office/ Office 365)
  • Fluent in English
  • 5 + years or more relevant regulatory affairs experience
  • Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
  • Specialized knowledge of regulatory activities for at least one major region (EU, US)
  • Ability to understand clinical and pre-clinical study results
  • Knowledgeable of clinical trials methodology
  • Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
  • Availability for domestic and international travel including overnight stays

Benefits

  • Health insurance
  • Retirement savings benefits
  • Life insurance
  • Disability benefits
  • Parental leave
  • Paid time off for sick leave and vacation

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