CMC Regulatory Specialist

1 week ago

Indianapolis, Indiana, United States Eurofins USA PSS Insourcing Solutions Full time
Job Title: CMC Scientist with GRA

At Eurofins USA PSS Insourcing Solutions, we are seeking a highly skilled CMC Scientist with GRA to join our team. As a key member of our regulatory team, you will play a critical role in ensuring the successful development and submission of our clients' clinical trial portfolios.

Job Summary:

The CMC Scientist with GRA will provide strategic, tactical, and operational direction and support to expedite the development of our clients' clinical trial portfolios. This includes developing successful regulatory strategies and submissions in support of clinical trials, as well as influencing and executing regulatory strategies that can accelerate the development of assigned projects.

Key Responsibilities:
  • Lead the preparation, technical and regulatory review, and finalization of CMC sections for global CTA submissions and respond to questions.
  • Take a proactive leadership 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.
  • Network and gain alignment with CMC team members and GRA-CMC regulatory scientists to resolve complex issues.
  • Assist in the development of regulatory strategy and update strategy based upon global regulatory changes.
  • 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.
  • Anticipate and resolve key technical or operational issues that can impact the function or CMC team.
  • Participate in risk-benefit analysis for regulatory compliance.
  • Develop relationships with GRA-CMC team members that promote open discussion of issues to enable regulatory influence of drug development strategies.
  • Communicate effectively verbally and in writing to influence within GRA-CMC and with CMC development team.
  • Demonstrate negotiation and influence skills. Demonstrate effective teamwork skills, able to adapt to diverse interpersonal styles.
  • Proactively identify and resolve global CMC regulatory issues.
  • 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:
  • Five or more years of global regulatory CMC experience, or equivalent experience supporting CMC functions contributing to clinical trial phases of development in various regions, including US, EU, and Asia. Or 5 years' experience in large molecule/biologics research and development or formulation.
Preferred Qualifications:
  • At least 3 years of large molecule/biologics in global regulatory CMC, research and development, or formulation.
  • Experience in authoring of CTA CMC submission content and responses to questions in various regions, including US, EU, and Asia.
Additional Information:
  • Position is full-time, working Monday-Friday 8:00 a.m.-5:00 p.m.
  • Overtime as needed.
  • Candidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply.
  • Excellent full-time benefits including comprehensive medical coverage, dental, and vision options.
  • Life and disability insurance.
  • 401(k) with company match.
  • Paid vacation and holidays.
  • #LI-EB1.
  • Authorization to work in the United States indefinitely without restriction or sponsorship.

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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