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Associate Director, Regulatory Affairs CMC

  • Job type: Permanent
  • Location: Bridgewater, New Jersey
  • Salary: US$130000 - US$150000 per year
  • Job reference: 340221/001_1562102654
  • Sector: EPM Scientific, Regulatory
  • Date posted: 02/07/2019

Associate Director, Regulatory Affairs CMC

Job Type: Permanent Full-Time

Location: Bridgewater, NJ

Salary: 130,000 to 150,000 per annum

Looking for an Associate Director, Regulatory CMC for a pharmaceutical client located in Central, NJ. The Associate Director, Regulatory CMC will be primarily responsible for providing leadership on CMC projects by developing/implementing CMC regulatory strategies and proposing mitigation plans to reduce risk.

My client is a well-known, reputable, mid-sized pharmaceutical company located in Central, NJ. They have grown 31% in the last 12 months, and show no signs of stopping!

Responsibilities

  • Lead CMC regulatory strategy planning/implementation for complex programs

  • Identify risk areas and create contingency plans

  • Manage execution of CMC documentation including IND/CTA, original BLA/MAA

  • Manage/mentor junior members of the team

Requirements

  • Bachelor's degree in a life sciences related field (Master's preferred)

  • 10+ years of CMC regulatory experience in the pharma/biotech industry

  • Prior management experience is preferred

  • Strong communication skills

Apply now if you're looking for an opportunity with huge growth potential!

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