Newark Metro Area, New Jersey
REGULATORY CMC BIOLOGICS
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
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