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Senior Regulatory Operations Associate

  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: Competitive
  • Job reference: 279681/002_1552329811
  • Sector: Medical Affairs, EPM Scientific
  • Date posted: 11/03/2019

Title: Senior Associate, Regulatory Operations

Company Summary: Innovative small yet stable biopharma in the South Bay area. Specializes in thrombosis and other hematologic diseases. With two approved drugs already beneath their belt and two clinical projects in their pipeline, the Senior Associate of Regulatory Operations will work alongside of the Regulatory team to format FDA electronic submissions and train/assist others.

The Senior Associate of Regulatory Operations will be responsible for:

  • Quality control checks with publishers for Regulatory source documents

  • Assist and train others on publishing tools

  • Contribute submission planning and publishing format

  • Support submission activities and authors to complete regulatory documents

The Senior Associate of Regulatory Operations should have the following qualifications:

  • BS/BA degree in life sciences or a related field

  • 3+ years of experience within Regulatory Affairs, medical writing, or medical publishing

  • Self-motivated individual requiring minimal supervision

  • Knowledge of FDA electronic publishing processes and submissions

  • Strong written and verbal communication skills

Benefits/Perks:

  • Competitive compensation package

  • Passionate and scientific environment

  • Work-life balance

  • Impressive PTO

If you are interested in the Regulatory Operations role, do not hesitate to apply!

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