Regulatory Affairs CMC Manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.

With our patients at the center of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

Qualifications

What do you need to have?
  • 5-8 years of relevant experience.
  • Bachelor's degree in relevant field of study.Master's degree preferred.
  • Advanced knowledge of regulatory CMC requirements for global drug development and post-market support initiatives.
  • Excellent written and oral communication skills.
  • Excellent presentation skills and ability to communicate effectively at multiple levels of the organization.
  • Ability to provide strategic regulatory guidance to drug development, registration, and postmarket support teams.
  • Ability to problem solve and apply skills to determine risk exposure and communicate
  • To qualify, applicants must be legally authorized to work in the United States or Canada and should not require, now or in the future, sponsorship for employment visa status.
ICON is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

Responsibilities

What will you be doing? Plan, execute and manage regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities with no supervision.Independently define CMC content (data and documentation) requirements for regulatory submissions and review this content for conformance with established requirements.As a project team leader or member, ensure and/or enhance regulatory compliance with respect to filing requirements for assigned compounds throughout development and the commercial life cycle.Evaluate change proposals for regulatory impact and filing requirements.Represent Regulatory Affairs CMC in Health Authority meetings and lead or support CMC preparation activities for meetings with Health Authorities on CMC-related matters.

United States-Remote
Canada-Remote
Canada-Remote