Regulatory Affairs - CMC Manager

Join a full service clinical contract research organization with a rapid pace of growth

  • Cincinatti, OH
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A bit about us:

We are a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective.

Why join us?

When you join, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.

We are continuing to grow in all areas globally and has built an expansive research campus at headquarters and expanding other locations across the country

Perks (vary by location and position):
  • On-site fitness center(s)
  • Campus walking paths
  • Company-sponsored social and wellness events
  • Official Sponsor of FC Cincinnati
  • Hybrid work-from-home options and flexible work schedule
  • On-site Market Place
  • Free and covered parking
  • Discounts for local businesses
  • On campus restaurants and banks coming soon

  • Recognized by Forbes as one of America's Best Mid-size Companies in 2021
  • We rank amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
  • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

Job Details

Our corporate activities are growing rapidly, and we are currently seeking full-time, office-based Regulatory Affairs Manager- CMC Subject Matter Expert (CMC). This person will work on a Regulatory Affairs (RA) project team to accomplish tasks and projects that are instrumental to the company’s success. With this opportunity, you will be able to leverage previous expertise and continue to develop and grow your career even further within the drug development industry.
  • Responsibility and accountability for the development and execution of global CMC strategy in support of clinical trial activities and RA project team goals across multiple projects;
  • Lead the preparation, development, and review of CMC documentation including Investigational Medicinal Product Dossiers (IMPDs), Module 3 documents, and Quality Overall Summaries, as well as the CMC sections of other regulatory documents, including scientific advice briefing documents and Investigator’s Brochures;
  • Act as the CMC point-of-contact within the RA project team, our company, and with Sponsors to provide end-to-end support and guidance within the contracted scope of the project;
  • Maintain up-to-date knowledge and understanding of global regulatory CMC requirements, guidance, conventions, and technologies;
  • Maintain timelines for CMC components of regulatory deliverables;
  • Ensure all CMC documents and deliverables are completed within the agreed upon timelines and developed with full compliance to all regulatory guidance, internal review and quality control processes; and
  • Support RA project teams and Sponsors in response to Regulatory Authority CMC queries and participate in meetings and teleconferences with Regulatory Agencies as needed. Ensure submissions comply with applicable regulations and guidance documents.
  • Bachelor’s degree in a Health or Science field- advanced degree preferred;
  • At least 5 years of prior experience in the research or pharmaceutical industry;
  • Working knowledge of CMC development strategy;
  • Experience in preparation of CMC documents (IMPDs and Module 3) in support of global regulatory filings;
  • Demonstrated experience managing CMC project deliverables, scope, and timeline
  • Strong computer skills, project management skills, and a high level of attention to detail;
  • Demonstrated strong communication (both written and oral) and interpersonal skills to positively influence internal and external teams; and
  • Ability to work independently with little to no guidance as well as demonstrate ability to act as a team player.

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