Job Details
Posted 8 May, 2026
Job Id: 627718
Regulatory Affairs Associate II
Job Description
Role Purpose:
Regulatory contractor for data management including data entry, review and labeling revisions. Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures that labeling is in compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of labeling components for regulatory dossiers. May review labeling, extract pertinent information, prepare information abstracts and executive summaries of material searched.
Major Accountabilities:
To ensure the smooth running of the Drug Regulatory Affairs Department through providing professional artwork review and preparation, and to contribute to the achievement of functional objectives. Applies company policies and procedures to resolve routine issues. Contacts are primarily with labeling team and other personnel in department or group. Works on problems of routine scope. Follows established policies and procedures. Normally receives detailed instructions on all work.
Education & Qualifications: BS in science or relevant field. Pharmaceutical and Regulatory Experience a plus.
Experience: Pharmaceutical and Regulatory Experience a plus.
Competencies: Computer literacy required. Strong organizational skills required.
Typical activities may include work at a computer, copying, scanning, filing and, dependent on the position, considerable time may be spent sitting, standing or walking. Light lifting (up to 10-15 lbs.) may be required from time to time, consistent with an office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Skills & Knowledge: Proficient in computer entry, Word, Excel, Powerpoint and internet use.
Pay ranges between 45-55/hr based on experience
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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