Sr Regulatory CMC Associate

Shirley, NY
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 136985

Date Posted: 03/14/2019


Title: Senior Regulatory CMC Associate 

Location: Shirley, NY - Relocation Package Offered 

Type: Full Time, Salaried with benefits 

Start Date: Immediate 
 

Pharmaceutical Company in Shirley, NY is hiring a Senior Regulatory Associate with a focus in CMC submissions to join their team! 

Responsibilities: 

  • Support the activities of the Regulatory Affairs department with strong focus in CMC. 
  • Lead the compilation, life-cycle, and compliance related to FDA submissions 
  • Mentor junior level CMC associates.
  • Leverages technical expertise and considers the evolving regulatory landscape to navigate project, product, or process changes.
  • Applies understanding of regulations to develop CMC information necessary to support each stage of new product development.
  • Proposes regulatory strategies for commercial changes and R&D activities to Regulatory Management for confirmation.
  • Authors and reviews regulatory submission documents ensuring accordance with FDA standards and regulatory guidance checks within specified timelines
  • Communicates CMC requirements for product development with project and sub-team members to drive submission timelines and determine risks to filing, escalating to management when appropriate.
  • Review and approve proposed changes to manufacturing processes, laboratory methods, and specifications.
  • Authors and/or provides critical review of SOPs, protocols, technical documents, and stability data and reports to ensure suitability for regulatory filing.

Requirements:  

  • Bachelor’s degree in Chemistry, Microbiology, Pharmacy, or other scientific field required.
  • Minimum of 4 years of Regulatory Affairs experience with a focus on CMC activities required. Ideally experience with US FDA NDA and ANDA submissions, facilitating the collection of deliverables from a manufacturing team.  
  • Experience with generic drugs or sterile products is highly desirable. CBE experience, experience with submissions life cycle would be great.
  • Prior experience communicating directly with the FDA
  • Prior experience acting as a lead for the CMC section of an NDA or ANDA submission from cradle to grave
  • Experience working in a QC lab/stability prior to regulatory work is helpful
  • Knowledge of FDA or EU drug regulations and cGMP requirements required.
  • Strong organizational, interpersonal and communication skills (oral and written).

 

For immediate consideration, please send resume to Gina at gscaccio@jouleinc.com  

 

 


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