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Regulatory Specialist

Newark Metro Area, NJ

Post Date: 07/24/2017 Job ID: JN -072017-19620

Will assist the Regulatory-CMC Biologics team with projects to support department goals and objectives.

Job Responsibilities require the following skills:

Attention to detail, excellent organization skills, good verbal and written communication skills are required. Ability to work independently on routine assignments with daily check-ins and to work cooperatively with senior staff providing key assistance on complex assignment. Computer experience must include familiarity with Word, Excel and PowerPoint

Job Duties:

Support Regulatory CMC Biologics group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global biologic applications.
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


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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