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Job Location: Framingham Area, MA
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Principal CMC Regulatory Affairs Associate
Boston, MA
Experts in rare genetic diseases within a global health care environment
Commitment to improving the patient's life with innovative and effective products
This is a challenging and exciting opportunity for anindividual contributor with key CMC Regulatory responsibilities in a rapid-paced biopharmaceutical environment:
Hands-on Regulatory CMC site lead role at companys manufacturing facility
o Short and long term regulatory strategy
o Site regulatory inspection support
o Recommending and/or approving changes that ensure compliance
Provide regulatory CMC support for
o Packaging
o Labeling
o Warehousing
o Testing
Technical documentation review of :
o Project Plans
o Change Control
o Deviations
o CAPA
o Batch Records
Experience & Education Qualification:
5 years of experience in the biotechnology or pharmaceutical industry
BS, MS or PhD in Biology, Chemistry, Engineering or related field
Biologics Compliance and regulations for:
o GMP
o FDA
o ICH
Post-marketing regulatory activities for biologics:
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