What are the responsibilities and job description for the Regulatory Affairs Specialist position at Sunrise Pharma?
POSITION DUTIES:
Responsible for ensuring compliance with FDA regulations, GMP and industry standards. Maintain and validate SOP 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.
POSITION REQUIREMENT:
Master’s Degree in Pharmaceutical Sciences with five (5) years of experience. 40 hrs/wk M-F.
PLACE OF EMPLOYMENT:
Sunrise Pharmaceutical Inc, 665 East Lincoln Ave., Rahway, NJ 07065.