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CMC Regulatory Scientist II

Regulatory CMC Scientist II

A global pharmaceutical corporation who dedicates themselves in improving and saving lives is seeking to hire two Regulatory CMC Scientist II for a year-long contract. This individual will be an impactful part of the CMC group.

The Regulatory CMC Scientist II will be responsible for: 1) Preparing and updating CMC sections and ancillary GMP documentation for of global Marketing Authorizations (MAA). 2) Executing regulatory filing strategies while ensuring that all regulatory documents are prepared accurately, completely and on-time. 3) Tracking project status and effectively communicating progress.

Duration: 12-month contract

Location: Rahway, New Jersey

Compensation: hourly rate negotiable

Requirements:

  • B.S. degree in Chemistry, Pharmacy or Engineering related field.
  • Minimum 3- 5 years Pharmaceutical CMC focused regulatory experience with most of the world filing emphasis.
  • Global experience is highly preferred.
  • Applicant should have experience conducting regulatory assessments, submission authoring and assembly using CTD structure, and eCTD lifecycle management.
  • Proven organizational skills and excellent written/verbal communication are required.
  • Applicant should have demonstrated writing skills, attention to detail and problem solving skills.
  • Proficiency needed in MS Office programs (Word, Excel, Outlook).
  • Must have GMP registration experience***
  • Prior experience with quality checks of submission documents is required.

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