Hiring Regulatory Affairs Associate II (Hybrid Remote)

• Job Title: Regulatory Affairs Associate II

• Duration: 12 Months Contract
• Location: Hybrid Remote @ 100 College Rd W, Princeton, NJ - 08540
• Hybrid working once fully trained. More on site presence whilst training.
• 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.
• Additional Duties:
• 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.

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