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Associate Director Regulatory Affairs

Company: EPM Scientific
Location: Cambridge
Posted on: January 15, 2022

Job Description:

Associate Director, Regulatory Affairs CMC
Location: Philadelphia, Pennsylvania OR Cambridge, Massachusetts
A fast growing and impressive pharmaceutical company is looking to add an Associate Director of Regulatory Affairs CMC to their rapidly growing team! This individual will be responsible for CMC strategies and regulatory applications and submissions, as well as supporting the global products within the companies impressive pipeline.
Responsibilities:

  • Develop regulatory CMC strategies through an array of activities (IND, BLA, CTA)
  • Provide review and guidance when it comes to CMC documents and submissions
  • Participate in regulatory CMC capabilities through business practices, training, and cross functional team work
  • Interpret and communicate information regarding CMC guidance, change controls, documents and regulations, and analytical development
  • Represent regulatory CMC team in forums to ensure achievement of the company's regulatory department to stakeholders and partners
    Qualifications
    • Bachelors degree required, further degree desired in a life sciences area
    • 7+ years of experience in Regulatory CMC
    • Knowledge of current global regulations in regards to CMC, molecular biology, and biochemistry
    • Ability to apply scientific knowledge to CMC and scientific content and present in a clear and concise manner
    • Strong leadership and communication skills

Keywords: EPM Scientific, Cambridge , Associate Director Regulatory Affairs, Executive , Cambridge, Massachusetts

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