Job Summary
A contract research organization is filling a position for a Telecommute Regulatory Affairs Manager.
Candidates will be responsible for the following:
- Developing and may lead the execution of regulatory CMC development and registration strategies
- As a project team leader or member, ensuring and/or enhancing regulatory compliance with respect to filing requirements
- Evaluating change proposals for regulatory impact and filing requirements
Applicants must meet the following qualifications:
- Bachelor's degree in relevant field of study
- 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 problem solve and apply skills to determine risk exposure and communicate potential issues to management
- Ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams
