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CMC Regulatory Consultant

  • Job type Contract
  • Salary competitive
  • Location East Hanover, New Jersey
  • Sector Pharma & Biotech

CMC Regulatory Consultant

A pharmaceutical corporation located in North Jersey is seeking to hire a CMC Regulatory Consultant on a contract basis. The CMC Regulatory Consultant will be providing strategy and some operational global CMC regulatory direction and documentation for projects/products covering development, registration and approval/post approval activities.

The CMC Regulatory Consultant will be responsible for: 1) formulating and driving global CMC regulatory strategy for development projects or marketed products, conduct risk assessments and develop mitigation strategies. 2) Act as a representative for Global Regulatory Affairs CMC on interdisciplinary project teams and maintain sound working relationships with partners and customers. 3) Lead global CMC submission activities including change request evaluation, identifying required content to ensure compliance in meeting global regulatory requirements. 4) Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.5) Author and/or review CMC documentation for Health Authority submissions.

Duration: 8-month contract

Location: East Hanover, New Jersey

Requirements:

  • Education: must have a Bachelors degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biology, Biotechnology) or equivalent required; Advanced degree is highly preferred
  • 3 years pharmaceutical industry experience in CMC drug development, QA/QC, and/or Technical Operations is required
  • Must have 2-6 years regulatory CMC experience
  • Working knowledge of global regulatory requirements and experience in regulatory submissions, approvals, and product life cycle management

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