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North American Regulatory Expert

3+ years
Not Disclosed
10 Jan. 13, 2025
Job Description
Job Type: Full Time Education: PhD/ PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Regulatory Expert

Location: Cincinnati, Ohio (Office-based)
Department: Regulatory Affairs
Company: Medpace


Job Summary

We are seeking a full-time Regulatory Expert to join our growing team in Cincinnati. In this role, you will serve as a key liaison with the FDA and other regulatory authorities, leading the development and implementation of regulatory strategies to ensure rapid approval with optimal labeling. This position demands strategic leadership, in-depth knowledge of North American regulatory science, and a thorough understanding of drug and biologic development processes.


Responsibilities

  • Develop and implement expert regulatory strategies to meet industry standards and achieve successful approvals.
  • Guide project teams on regulatory strategies throughout clinical development.
  • Collaborate on strategic projects such as gap analyses, regulatory authority meetings, and protocol synopsis reviews.
  • Stay current with evolving regulatory requirements and provide proactive guidance.
  • Maintain effective communication and relationships with national and regional regulatory agencies.
  • Conduct detailed reviews of regulations and guidelines to propose solutions to regulatory challenges.
  • Provide expert advice to internal teams, including Clinical Operations, Medical Writing, Clinical Safety, Data Management, and Biostatistics.

Qualifications

  • PhD in Life Sciences or PharmD required.
  • Minimum 3 years of regulatory affairs experience in a CRO or pharmaceutical setting.

About Medpace

Medpace is a globally recognized clinical contract research organization (CRO) providing end-to-end clinical development services. With 30+ years of expertise, we partner with the biotechnology, pharmaceutical, and medical device industries to accelerate the development of life-changing therapies. Our headquarters in Cincinnati, Ohio, leads operations in over 40 countries with more than 5,000 employees worldwide.


Why Join Medpace?

People. Purpose. Passion.

  • Be part of a team that has positively impacted countless lives over three decades.
  • Work on projects that improve patient outcomes and advance global healthcare.

Cincinnati Perks

  • Modern Campus: Eco-friendly, with an on-site fitness center.
  • Flexible Work Environment: Competitive PTO starting at 20+ days.
  • Career Development: Structured growth paths and discounted tuition for UC online programs.
  • Community Engagement: Opportunities to support local nonprofits and enjoy discounts on sports games, attractions, and fitness centers.
  • Employee Wellness: Health initiatives and company-sponsored appreciation events.

Awards and Recognition

  • Named a Top Workplace 2024 by The Cincinnati Enquirer.
  • Listed among America’s Most Successful Midsize Companies by Forbes (2021–2024).
  • Winner of CRO Leadership Awards for excellence in expertise, quality, and reliability.

What to Expect Next

Your application will be reviewed by a Medpace team member. If your qualifications align with our needs, we will contact you regarding the next steps in the process.


Apply Today to shape the future of global healthcare with Medpace.

Medpace is an Equal Opportunity Employer, embracing diversity, including individuals with disabilities and veterans.