SRG is a global staffing and consulting firm and we are looking for a strong Site Compliance Specialist for a 6-9 month project in Marietta, PA!
• Perform all job responsibilities in compliance with applicable EHS and GMP regulations, guidelines, policies, standard operating procedures, and industry practice.
• Single point of contact between all Regulatory Affairs functions and site.
• Site regulatory expert – responsible for interpretation of regulatory requirements and advice regarding regulatory conformance.
• Responsible for assessing all change controls for Regulatory impact and for assessment (with Regulatory Affairs) of the level of change for change controls with regulatory impact.
• Responsible for planning all regulatory applications following the Vaccines Regulatory Submission Building process and responsible for the internal review and approval of CMC dossiers business process outlined by LSOP 9000040603.
• Responsible for planning and coordinating all responses to Regulatory information requests and the business process outlined by LSOP 9000040605, provide CMC and regulatory file information to the site.
• Responsible for organizing and coordinating the actions of teams responsible for preparing regulatory submissions so that regulatory submissions are prepared accurately, completely, and on time.
• Responsible for local coordination of license renewal requests.
• Responsible for maintaining the Core Files and the Site Master File.
• Member of the local inspection team during regulatory inspections.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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