Senior Regulatory Writer

Location: New Jersey

Salary: Commensurate with experience

Our client is a growing Pharmaceutical company in the Central New Jersey Area looking to hire a Senior Regulatory Writer.

They currently have multiple approved products (branded, specialty and generics) on the market and are in the process of expanding their pipeline in neurology, rheumatology, nephrology, pulmonology, and ophthalmology. This is a great opportunity to work in a fast-paced environment with an opportunity to gain significant exposure, and the potential to advance internally.

This individual would partner directly with Global Regulatory contacts and supports project teams across multiple compound and/or projects to ensure the development of high-quality, message-focused, submission-ready, regulatory documents.

Job Responsibilities:

  • Plans, writes, edits, and reviews clinically focused regulatory documents, Common Technical Document Module 2 clinical-focused documents and Module 5 integrated summaries, pediatric study plans, and Health Authority responses.
  • Ensures document quality regarding agreed upon key messages, compliance with Standard Operating Procedures (SOPs) and Health Authority guidance, and consistency with applicable style guides and document conventions

Job Requirements:

  • 5+ years of Regulatory writing/documents experience (writing/publishing and submissions) & a minimum of 7 years of drug/biologics development experience
  • Module 2 and Module 5 experience
  • Bachelor’s degree with regulatory or medical writing experience in the pharmaceutical/biotechnology/medical device industry