Job Details

  • Title: Regulatory CMC Manager
  • Code: RCI-35902-1
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 02/25/2021
  • Duration: 12 Months
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  Job Description

The Consultant will be based in Summit, NJ and 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 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 Cell Therapy group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global cell therapy applications.
  • Qualifications
  • Must have 5-7years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 1-3 years of Biologic / Cell Therapy Regulatory CMC experience, including the preparation of Biologic / Cell Therapy CMC dossiers
  • At least a bachelor’s degree required
Skills/Knowledge Required:
  • REQUIRED: Experience with Biologic / Cell Therapy CMC regulatory documents (MAA, BLA, supplements, meeting requests and briefing books responses and IND/CTAs)
  • REQUIRED: Experience with CMC regulations for biological / cell therapy compounds
  • A PLUS: Experience with Gene/Cell/CAR T Cell therapy CMC regulations
  • REQUIRED: Practical knowledge of FDA, EMEA, Canadian and ICH guidelines
  • A PLUS: Practical knowledge of rest of world post approval guidelines
  • REQUIRED: Have a solution-oriented approach to problem solving
  • A PLUS: Expertise in the biologic / cell therapy drug development process and post approval activities
  • REQUIRED: Ability to work on complex projects and within cross-functional teams