Company Description

If you're experienced in pharmaceutical formulations or chemistry manufacturing and controls, but you're interested in taking your career into a non-lab, regulatory affairs space, this is a great opportunity for a career pivot!

Job DescriptionLeads preparation, technical, and regulatory review and finalization of CMC sections for global CTA submissionsTakes a proactive role in the critical review of molecule specific GRA-CMC development strategies and submission content. Makes 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 decisionsEvaluate regulatory impact on proposed CMC development plansCommunicates effectively verbally and in writing to influence within GRA-CMC and with CMC development team.Partners with Client GRA CMC (regulatory scientists) develop complex regulatory strategies.Partners with Client RDE (regulatory associates/publishing group) to ensure completion of submission activities.

Qualifications

Minimum Qualifications:

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).

Preferred but Optional:

Three or more years of direct 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. 

Additional InformationPosition is full-time, working Monday-Friday 8:00 a.m.-5:00 p.m, overtime as neededCandidates currently living within a commutable distance of Indianapolis, IN are encouraged to apply.Excellent full-time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysAuthorization to work in the United States indefinitely without restriction or sponsorship

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