USRA Regulatory Compliance Manager
Site Name: USA - North Carolina - Research Triangle Park Posted Date: Oct 12 2021 Do you have experience in pharmaceutical promotional review and approval processes, including direct experience in submissions of promotional materials to the FDA as a Regulatory requirement to enable promotion compliance in US markets? If so, this USRA Regulatory Affairs Compliance Manager role could be an ideal opportunity to explore. The USRA Regulatory Compliance Manager will help guide process, training, and monitoring to enable the timely completion and submission of Form FDA 2253 and associated assets, as well as other promotional submissions to FDA. This role will be accountable for managing workload priorities, promotional filing compliance, and effective matrix relationships with Regulatory Advertising and Promotion Teams, Global Regulatory Publishing, Content Strategy & Operations, and Marketing stakeholders across all US Business Units. Additionally, the role includes governance of select promotional compliance processes to include associated Training, Reporting, Standard Operating Procedures (SOPs), Quality Initiatives, and Controls and Monitoring, as applicable. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Ensure a streamlined electronic process to enable accurate and timely completion of promotional submissions to FDA including: 1) Form FDA 2253 and accompanying promotional assets; 2) Accelerated Product Hold submissions; and 3) Advisory submissions, as needed. Support oversight of process, performance, and strategy for electronic Common Technical Document (eCTD) delivery of FDA promotional submissions for all US business products and launches. Accountable for leading continuous improvement initiatives in support of Regulatory governance priorities and FDA promotional filing processes. Enable effective processes and system functionality working with matrix stakeholders. Accountable for development, stakeholder review, and management of Standard Operating Procedures (SOP) and Work Instruction Documents for required Regulatory processes. Accountable for specific Controls and Monitoring processes to ensure compliance with relevant SOPs. Provide training and documentation, as needed, to all roles participating in eCTD processes supporting FDA promotional submissions to ensure ongoing proficiency and compliance. Support US Regulatory staff in FDA eCTD filing processes, system functionality, and operational troubleshooting. Collaborate with stakeholders in Marketing, Regulatory, Legal, Medical, Content Strategy & Operations, and Compliance to develop solutions that ensure compliant process execution. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: 3 plus years of experience working in Pharmaceutical Commercial Operations OR Regulatory Operations Knowledge and/or experience in pharmaceutical promotional review and approval processes, including knowledge and/or experience in electronic/eCTD filing, and /or filing of Form FDA 2253 and other promotional submissions (eg, Advisory, Pre-clearance) as a Regulatory requirement Knowledge and/or experience in leading and managing the execution of processes, projects, and matrix contributors within a team Preferred Qualifications: If you have the following characteristics, it would be a plus: Knowledge of Form FDA 2253 submission process in Veeva electronic routing systems Knowledge / awareness of the Regulatory environment, FDA Guidelines, laws and regulations Demonstrated ability for writing of Standard Operating Procedures (SOPs), Work Instruction Documents, and control monitoring Demonstrated ability to develop content and train others on key processes Strong presentation skills; training development and delivery experience Demonstrated ability to manage and troubleshoot process/system complexity Demonstrated ability to influence key stakeholders in matrix environment Demonstrated application of ADP principals to identify opportunities for process improvement and deliver successful solutions Strong verbal and written communication skills Ability to work independently without direct supervision Completion and submission of Form FDA 2253 and accompanying promotional items to FDA during product launches *This is a job description to aide in the job posting, but does not include all job evaluation details. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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