Regulatory Affairs Associate

Highly Competitive Salary
  1. Permanent
  2. Officer /Associate, Publishing & Submissions, RA Intelligence
  3. United States
Boston, USA
Posting date: 17 Mar 2021

Proclinical is currently recruiting for a Regulatory Affairs Associate with a biotechnology company located in Boston, MA. This is an entry level role with the opportunity to learn and develop within the Reporting & Submissions team in Global Case Management with a focus on regulatory intelligence and associated activities.

Job Responsibilities:

  • Monitoring of submissions
  • Generating / reviewing metrics
  • Inspection / audit readiness
  • Assisting with quality reviews
  • Ongoing training and other tasks, as assigned.

Skills and Requirements:

  • Bachelor's Degree Required
  • Minimum 6 months to one year industry experience, preferably in pharmacovigilance or regulatory area.
  • Understanding of global regulatory and pharmacovigilance terms and activities.
  • Ability to read and interpret global regulations / documents as received from various sources such as Cortellis
  • Ability to identify, analyse, and summarize requirements / legislations related to Pharmacovigilance.

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.