Job Description

Consultant (Global Regulatory CMC Cell Therapy)
Job Number: 21-08995
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Consultant (Global Regulatory CMC Cell Therapy) for our client in Summit, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

  • Assist the Regulatory-CMC Cell Therapy team with projects to support department goals and objectives.
  • Support Regulatory Cell Therapy group in the preparation of submissions. These submissions include briefing books, IND/CTA, BLA, MAA and global cell therapy applications.
Required Qualifications:
  • Must have 5-7 years 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.
  • 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 / cell therapy compounds
  • Practical knowledge of FDA, EMEA, Canadian and ICH guidelines.
  • Have a solution-oriented approach to problem solving
  • Ability to work on complex projects and within cross-functional teams
  • 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
  • Experience with Gene/Cell/CAR T Cell therapy CMC regulations
  • Expertise in the biologic / cell therapy drug development process and post approval activities
  • Practical knowledge of rest of world post approval guidelines
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Jane Bautista
Jane Bautista | LinkedIn

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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