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CMC Biologics - Consultant

Newark Metro Area, New Jersey

Post Date: 02/28/2017 Job ID: JN -022017-18488
CMC Biologics - preparation of submissions including briefing books, IND/CTA, BLA, MAA and global biologic applications.

Qualifications
Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 5 years of Biologic Regulatory CMC experience, including the preparation of Biologic CMC dossiers
At least a Bachelor Degree required. Master s Degree or PhD preferred

Skills/Knowledge Required:

Extensive experience with Biologic CMC regulatory documents (MAA, BLA, supplements, meeting requests and briefing books responses and IND/CTAs)
Experience with CMC regulations for biological compounds
Experience with Gene/Cell/CAR T Cell therapy CMC regulations
Practical knowledge of FDA, EMEA, Canadian and ICH guidelines.
Practical knowledge of rest of world post approval guidelines
Have a solution-oriented approach to problem solving
Expertise in the drug development process and post approval activities
Ability to work on complex projects and within cross-functional teams

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