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Real Staffing

Regulatory Specialist CMC Biologics

Post Date:Jan 02, 2018Type:Full-Time
Start Date:1/2/2018Salary:£0.00
Location:US-NJ-Summit Job Reference:RE-32787649

Job Description:

Our client, a leader in the Biopharmaceutical industry is seeking a Regulatory Specialist with experience in CMC Biologics, to join their team on a 12-month contract basis. This individual must have a experience working with Cell Therapy, QA and dossier preparation.

Responsibilities include but is not limited to:

  • Support Regulatory CMC Biologics group in the preparation of submissions, include briefing books, IND/CTA, BLA, MAA and global biologic applications.
  • Ability to work independently on routine assignments with daily check-ins and to work cooperatively with senior staff providing key assistance on complex assignment


  • Must have 7-9 years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA
  • 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

Sthree US is acting as an Employment Business in relation to this vacancy.

Contact Information
Real Staffing
Name: Noah Joseph
Ph: +1 212 707 8499

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