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Description:
The contractor will assist the Regulatory-CMC Cell Therapy team with projects to support department goals and objectives. Job Responsibilities require the following skills: Attention to detail, excellent organizational skills, good verbal and written communication skills are required. Ability to work independently on routine assignments with regular check-ins and to work cooperatively with senior staff providing key assistance on complex assignments. Computer experience must include familiarity with Word, Excel and PowerPoint

Support Regulatory CMC Cell Therapy group in the preparation of submissions. These submissions include briefing books, IND, CTA (IMPD), BLA, MAA applications.

Qualifications

Must have 5+ years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 1-3 years of Cell Therapy or Biologics Regulatory CMC experience, including the preparation of Cell Therapy or Biologics CMC dossiers
At least a bachelor's degree required.

Skills/Knowledge Required:

REQUIRED: Experience with Cell Therapy or Biologics CMC regulatory documents (IND, IMPD, amendments, meeting requests and briefing books, responses to questions)
REQUIRED: Experience with CMC regulations for cell therapy or biological compounds
A PLUS: Experience with Cell Therapy CMC regulations
REQUIRED: Practical knowledge of FDA, EMEA, Canadian, and ICH guidelines.
A PLUS: Practical knowledge GMO or NSN applications, and of rest of world guidelines
REQUIRED: Have a solution-oriented approach to problem solving
A PLUS: Expertise in cell therapy or biologic drug development process activities
REQUIRED: Ability to work on complex projects and within cross-functional teams