CMC Consultant in Jersey City, NJ at Integrated Resources, Inc

Date Posted: 9/8/2020

Job Snapshot

Job Description

Job Title:  Consultant – CMC (Regulations)

Location: Jersey City, NJ

Duration: 12 Months (possibility to become permanent for the right candidate)

Description:

Our Client is looking for a candidate that has a strong background in CMC (particularly CMC regulation), pharma development, and pharma regulation. Past experience with a Japanese pharmaceutical company is preferred.

Background in CMC Writing will not be sufficient for this role.

Key Responsibilities:

  • 5-10 years of experience Only
  • Contributes to development of programs/processes that support development of Investigational or New Drug Applications.
  • Collaborates with CMC counterparts in Japan and other departments to execute CMC submission activities, including meeting requests and briefing documents for FDA meetings, and INDs/NDAs submitted to regulatory agencies.
  • Executes the timely preparation, review and submission of high-quality CMC content for submissions of all types and their amendments and supplements as assigned.
  • Lends functional expertise and supports CMC related discussions, negotiations and responses with FDA and internal stakeholders such as Production Technology, Quality Operations, Commercial manufacturing, Supply chain, etc.    
  • Interfaces with technical, and regulatory in Japan, as required, on CMC related projects and issues.
  • Support global CMC process development and improvement as required.
  • Provides ongoing lifecycle support for marketed commercial products.
  • Evaluates and contributes to the outsourcing of manufacturing efforts and change controls, the assessment of regulatory impacts, and provides support for their implementation.
  • Represents Regulatory Affairs CMC function, as required, at various cross-functional team meetings and working group meetings, providing solutions when possible to the project teams on CMC related problems. Escalates more complex issues to the Sr. Director, CMC.
  • Maintains up-to-date knowledge of relevant FDA and ICH requirements relating to CMC activities.
  • Advises and updates teams on the impact of new legislation, regulations and guidance on development plans and registration strategy as it relates to CMC sections for INDs/NDAs.