Remote Senior Regulatory Affairs CMC Specialist in Philadelphia

Location: Pennsylvania

Compensation: Salary

Staff Reviewed: Thu, Jul 22, 2021

This job expires in: 26 days

Job Category: Healthcare

Remote Level: 100% Remote

Employer Type: Staffing Agency

Education Level: Bachelors, Masters

Job Summary

A staffing agency is seeking a Remote Senior Regulatory Affairs CMC Specialist in Philadelphia.

Core Responsibilities of this position include:

  • Supporting and managing the regulatory activities associated with CMC
  • Providing input into the product strategy and to the direction
  • Assuring the established regulatory strategy is aligned with Health Authority requirements

Must meet the following requirements for consideration:

  • BS/BA Degree in a Scientific Discipline
  • Experience working in pharmaceutical Regulatory CMC
  • Or pharmaceutical Regulatory CMC experience with relevant pharmaceutical experience
  • Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions
  • Understanding of scientific principles and regulatory CMC requirements
  • Proven ability to provide strategic regulatory guidance to drug development teams

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