Associate Director Regulatory Affairs CMC

Details

Country: USA
Location: New Jersey-Northern statewide, NJ
Total applied: 40
Job Category:Biotech/R&D/Science
Relevant Work Experience:5+ to 7 Years
Location:statewide, NJ
Status:Full Time, Employee
Occupations:Biological/Chemical Research;Clinical Research;Pharmaceutical Research
Career Level:Manager (Manager/Supervisor of Staff)
Relevant Work Experience:5+ to 7 Years

Associate Director, Regulatory Affairs, CMC

Responsibilities include:

Directing the RA strategy in support of IND developmentWorking on international project teamsNew dosage form developmentActing as the US representative on Change Control committeesLiaising with FDA

Requirements:

5-8 years Regulatory CMC experience plus 1-2 years of related pharmaceutical experienceadvanced degree in scientific discipline, advanced degree in chemistry or pharmacy preferredstrong biologics and small molecule experience requiredinternational regulatory CMC experience required (second position requires Biologics experience, 8-10 yrs. experience)

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