CMC Regulatory Affairs Manager – Jersey City, NJ

Role posted on: 9th November 2018

We have an opportunity with an International Biotech organization for a Regulatory Affairs CMC Manager. We are looking for someone who has experienced in development and approved products. The role is full time, based primarily in NJ and starting immediately.

The Manager will be responsible for supporting, strategically developing and maintaining clinical study and CMC timelines, providing evaluations of potential risks and conflicts, supporting the team on proactively resolving potential deviations, and presenting clear timeline reports. You will be working in a team-orientated environment and will be empowered to drive clinical studies and CMC activities with minimal deviations, accelerating timelines and providing metrics to implement future enhancements.

Role Description: CMC Regulatory Affairs Manager – Jersey City, NJ

  • Develop and maintain high quality, realistic, cross functional clinical trial plans. The CMC Manager will develop timelines when the synopsis/draft protocol is available.
  • Develop and maintain high quality, realistic Chemistry, Manufacturing & Control (CMC) plans for products in development.
  • Partner with Project Management and Regulatory Affairs to implement project strategies and improve efficiency by identifying and implementing new business processes.
  • Develop and maintain NA/ROW timelines to meet all deliverables.
  • Partner with the Clinical Development lead, Global Operations department and the study team to ensure timely delivery of all milestones. The Manager, Clinical and CMC Planning will be expected to identify gaps and risks in the study plans and work with the team and Management to proactively develop solutions which will increase efficiency and minimize timelines.
  • Partner with Pharmaceutical Sciences Strategy to ensure timely delivery of all CMC milestones. The Manager, Clinical and CMC Planning will be expected to identify gaps and risks in the CMC plans and work with the team and Management to proactively develop solutions which will increase efficiency and minimize timelines.
  • Define baselines and provide metrics to identify areas and trends that can be used by the teams for future enhancements.
  • Responsible for arranging and leading discussions on the clinical study and CMC plans.
  • Present clear CMC plan reports to stakeholders.
  • Operate within the Governance Board model for communication and accountability.
  • Provide continuous improvement on CMC plans and standard MS Project templates. * Assist in developing the department portfolio based schedules and resource planning methodologies.
  • Identify state of the art planning tools to minimize deviations from established timelines.

Criteria

  • 4-8 years CMC experience
  • Role is to prepare pre and post approval CMC submissions for US and Canada (plus EU optional)
  • 40 hours per week, long term [indefinite] engagement
  • Immediate start
  • Required to be on-site 2 or 3 days per week Jersey City, NJ

 

If you would be interested in joining the team at G&L Scientific, please send your CV to talent @ gandlscientific.com today.

G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individ

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