Veristat

Senior Regulatory Affairs Manager

Veristat

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

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Salary

💰 $125,000 - $160,000 per year

Job Level

Senior

About the role

  • Manage assigned regulatory and cross-functional projects.
  • Provide strategic and operational support to clients in regulatory decision-making processes.
  • Work with project teams, provide advice on regulatory agency interactions.
  • Manage agency communications and support the preparation of submissions.
  • Create strong rapport with clients.

Requirements

  • Bachelor’s degree in a related field required.
  • Advanced scientific degree (i.e. PhD or Master’s degree) preferred.
  • 6 - 8 years of regulatory affairs experience in a clinical research organization and/or pharmaceutical setting.
  • Thorough knowledge of International Conference on Harmonisation (ICH) guidelines and regulatory guidelines.
  • Excellent written and oral communication skills including grammatical/technical writing skills.
  • Familiarity with drug development, agency interactions, study designs and regulatory requirements that apply to clinical trials.
Benefits
  • Remote working
  • Flexible time off
  • Paid holidays
  • Medical insurance
  • Tuition reimbursement
  • Retirement plans
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory affairsclinical researchtechnical writingdrug developmentstudy designregulatory submissionsagency interactionsregulatory guidelinesInternational Conference on Harmonisation (ICH) guidelines
Soft Skills
strategic supportoperational supportcommunication skillsrapport buildingadvisory skills
Certifications
Bachelor’s degreePhDMaster’s degree