Regulatory Affairs Specialist

About This Role

This specialist position involves ensuring compliance with FDA regulations, GMP, and industry standards within a pharmaceutical manufacturing environment. The role focuses on maintaining regulatory adherence across production, packaging, and analytical testing processes, and providing guidance to various teams.

Responsibilities

• Ensure compliance with FDA regulations, GMP, and industry standards
• Maintain and validate SOPs to ensure adherence to regulations and guidelines
• Oversee the accuracy and regulatory compliance of production and packaging records, including batch records, analytical records, and labeling
• Manage the issuance and control of master documents across departments, ensuring proper documentation of controlled copies
• Perform analytical testing for raw materials, in-process materials, stability testing, and finished drug products
• Conduct inspections and sampling of raw materials, in-process, and finished drug products for commercial, validation, and ANDA batches
• Review test results and analytical reports to ensure compliance with GMP standards and SOPs
• Conduct internal audits to assess manufacturing operations and identify areas for improvement
• Provide regulatory guidance, written reports, and verbal presentations on analytical data, methods, and interpretations to other departments
• Collaborate with R&D, manufacturing, and quality control teams to ensure seamless product development and regulatory compliance
• Calibrate and troubleshoot analytical instruments, including pH meters, dissolution apparatus, high-performance liquid chromatography (HPLC) systems, and UV spectrophotometers

Requirements

• Master’s Degree in Pharmaceutical Sciences
• Five (5) years of experience

Important Details

• Schedule: 40 hours per week, Monday-Friday

About the Company

Sunrise Pharmaceutical Inc. is located at 665 East Lincoln Ave., Rahway, NJ 07065.