Associate Director, Regulatory CMC
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Employment Type: Full Time
Experience: 5 years or more
Full-Time Salary Range: $90,000 to $120,000
Job Description: Direct the regulatory strategies in support of commercial and investigational drug development. Support and/or lead new dosage form development initiatives as well as regional and international project teams. Act as the US representative on the Corporate R&D and commercial Products Change Control Committees. Liaise with FDA and regulatory authorities as required. Arrange and provide RA support for foreign FDA inspections.
Qualifications: 5-8 years regulatory CMC experience. 1-2 years pharmaceutical related experience. Chemistry and Regulatory backgrounds, necessary, primarily in the Analytical Chemistry and Formulations Development area.
Skills: Candidate must have excellent organizational and communication skills.
Education: Bachelor's degree in scientific discipline required. Advanced degree in chemistry or pharmacy preferred.