Job Details

  • Title: Consultant - Global Regulatory CMC Biologics/Cell Therapy
  • Code: RCI-32937-1
  • Location: Summit New Jersey (NJ) 07901
  • Posted Date: 09/16/2020
  • Duration: 6 Months
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  Job Description

  • The Consultant will be based in Summit, NJ and will assist the Regulatory-CMC Biologics/Cell Therapy team with projects to support department goals and objectives.

Responsibilities:

  • 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 & Cell Therapy group in the preparation of submissions.
  • These submissions include 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/Cell Therapy Regulatory CMC experience, including the preparation of Biologic/Cell Therapy CMC dossiers
  • At least a bachelor’s degree required. Master’s Degree or PhD preferred

Skills/Knowledge Required:

  • Extensive experience with Biologic/Cell Therapy 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