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CMC Regulatory Affairs Specialist (contract)

  • Job type: Contract
  • Location: Hackensack, New Jersey
  • Salary: Competitive
  • Job reference: 184011/002_1530881417
  • Sector: EPM Scientific, Regulatory
  • Date posted: 06/07/2018

CMC Regulatory Affairs Specialist (contract)

Looking for a CMC Regulatory Affairs Specialist for a 6 month contract position in New Jersey. The CMC Regulatory Affairs Specialist will be responsible for reviewing/writing a high volume of regulatory documents.

My client is a small pharmaceutical company located in New Jersey. They are opening a new facility on Long Island in the next 6 months, so there are lots of documents to review before then.

Responsibilities

  • Write CMC sections of regulatory dossier of sterile injectable products

  • Manage the interface between the Manufacturing Site and Regulatory CMC group to maintain product regulatory conformance

  • Discuss/align with the project team on strategy for maintenance activities for products under his or her responsibility

Requirements

  • Bachelor's in a life sciences related field

  • 5+ years of relevant CMC regulatory experience

  • Hands on experience with sterile injectable products

  • Prior experience working with biologic products (plasma products preferred)

Apply now - looking to have someone start as early as July 16th!

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