Regulatory Affairs Associate Job Description

Regulatory Affairs Associate Job Description Template

Our company is looking for a Regulatory Affairs Associate to join our team.

Execute established business processes and may assist in development and implementation of process and system changes or data remediation projects;
Participate and contribute in group, department and cross-functional meetings and may assist in training junior team members;
Troubleshoot errors and system performance issues and work with their supervisor and IT on business problem resolution and enhancements;
Maintain global regulatory files and databases to ensure accurate and up-to-date information;
Facilitate the label/marketing material review process to ensure timely review of necessary documents;
Participate in regulatory monitoring and impact analysis for Global business requirements;
Participates in the review and approval of professional and consumer facing communication (LCR Process) for compliance with applicable US regulations.

Possess a bachelor’s degree or higher in a science or engineering discipline (completed and verified prior to start);
Strong analytical capability, problem solving skills, and database management;
Demonstrated analytical and communication skills;
Possess a High School Diploma/GED or higher (completed and verified prior to start) from an accredited institution;
One (1) or more years of PPE or healthcare experience in a private, public, government, or military environment;
Excellent interpersonal, written, and oral skills and demonstrated leadership;
Process documentation;
Any kind of regulatory experience;
Analytical skills, make sure the information is clean and accurate;
Demonstrated analytical and problem solving skills;
Proven computer skills (Microsoft Word, Excel, PowerPoint, Project, Outlook);
Detail-oriented and critical thinker;
Excellent written and verbal communication skills;
Experience working with others in a team environment;
Detail oriented with problem solving ability.