Head of Regulatory Operations

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

  • Cincinatti, OH
Easy Apply Now

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

Awards:
  • 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 clinical activities are growing rapidly, and we are currently seeking a full-time, Head of Regulatory Operations to join our team. This position is accountable for the development and implementation of the regulatory strategy for specific Sponsor projects, for ensuring that the strategy is designed to deliver a rapid approval with advantageous labeling in keeping with the properties of the product(s) and the needs identified by the team. The RAD possesses strategic leadership skills, has deep experience in North American (US and Canada) regulatory science and overall drug/biologic development processes and strategies. Experience and knowledge of therapeutic areas and drug development is an important enabler to being able to influence cross-functional discussions Sponsors and relevant stakeholders.

Responsibilities

Primary Role: Lead the Regulatory Operations team comprised of 20 Regulatory Operations professionals responsible for submissions and regulatory information management

  • Develop and implement strategies related to submissions, processes, and systems supporting regulatory affairs
  • Act as line manager for four Regulatory Document Supervisors responsible for publishing and submissions activities
  • Manage internal CRO, client and vendor relationships
  • Act as business owner for regulatory information systems
  • Participate in business development efforts and proposal reviews

Qualifications

  • Bachelor's degree
  • 3 years of regulatory experience

Easy Apply Now
Easy Apply Now
Job Details
Managed by Jobot Pro
Location
Cincinatti, OH
Job Type
Permanent