Accessibility Links

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!

Similar jobs
Quality Technician and Inspector
  • Job type: Contract
  • Location: San Francisco, California
  • Salary: Competitive
  • Description Local Medical Device company in search of strong Senior Quality Control Inspector and Quality Technician. We are looking for someone who is not afraid to step in and make a change
Quality Engineer
  • Job type: Permanent
  • Location: Rochester, New York
  • Salary: Competitive
  • Description Title: Quality Engineer Salary: $60,000 - $80,000 + Benefits + Excellent Career Growth A medical device company that manufactures, develops, and markets minimally invasive surgical instruments is
Sr. Quality Manager GCP
  • Job type: Permanent
  • Location: Cambridge, Massachusetts
  • Salary: US$110000 - US$140000 per annum
  • Description Title: Sr. Quality Manager, GCP Salary: $110,000 - $140,000 + Bonus + LTI + Benefits Company Summary: One of the top global pharmaceutical companies is looking for a Sr
Head of Quality (QA/QC)
  • Job type: Permanent
  • Location: Walkersville, Maryland
  • Salary: Negotiable
  • Description Title: Head of Quality QA/QC Salary: $185,000 - $200,000 + Bonus + Benefits Company Summary: One of the top global suppliers to pharmaceutical, biotechnology, and speciality ingredient markets is
Head of Drug Safety & Pharmacovigilance
  • Job type: Permanent
  • Location: San Francisco, California
  • Salary: Negotiable
  • Description Head of Drug Safety & Pharmacovigilance Head of Drug Safety & Pharmacovigilance San Francisco, California A late-stage biopharmaceutical company focused on discovering, developing