Scientist - CMC Regulatory Expert

14 hours ago


Indianapolis, Indiana, United States Eurofins USA PSS Insourcing Solutions Full time
Job Title: Scientist - CMC Regulatory Expert

At Eurofins USA PSS Insourcing Solutions, we are seeking a highly skilled Scientist - CMC Regulatory Expert to join our team. As a key member of our regulatory team, you will be responsible for providing strategic, tactical, and operational direction and support to expedite the development of our client's clinical trial portfolio.

Key Responsibilities:

  • Lead the preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissions.
  • Take a proactive role in the critical review of molecule-specific GRA-CMC development strategies and submission content.
  • Make technical decisions on CMC regulatory issues impacting product submissions across geographies, with support or guidance from Client GRA-CMC regulatory scientists.
  • Provide high-quality, timely, and clear regulatory advice to allow CMC teams to make well-informed decisions.
  • Evaluate regulatory impact on proposed CMC development plans.
  • Communicate effectively verbally and in writing to influence within GRA-CMC and with CMC development teams.
  • Partner with Client GRA CMC (regulatory scientists) to develop complex regulatory strategies.
  • Partner with Client RDE (regulatory associates/publishing group) to ensure completion of submission activities.

Requirements:

  • Bachelor's Degree in a science discipline (chemistry, biology, biochemistry, or related scientific discipline).
  • Three to five years in research and development or formulation role focused on large molecule/biologics drug substance/product development.
  • Pharmaceutical industry experience in CMC technical drug development (drug substance and/or drug product experience in analytical development or formulation).

We offer a competitive salary, excellent benefits, and a dynamic work environment. If you are a motivated and experienced Scientist - CMC Regulatory Expert, please submit your application.



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