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
