Job
Description
The Senior Regulatory Administrator (SRA) role is crucial in providing vital administration and operational support to the Regulatory Affairs department. As an SRA, your primary responsibility is to ensure the efficient management and upkeep of regulatory documents within the regulatory systems. Your pivotal role involves overseeing the accuracy, compliance, and timely submission of regulatory documentation to regulatory bodies such as the FDA, EMA, and other international authorities. Your duties will include managing the organization of regulatory documents for submissions, ensuring adherence to relevant guidelines and regulations, optimizing processes, mentoring team members, and fostering collaboration across departments to enhance our regulatory operations. Key responsibilities of the job include, but are not limited to: - Uploading, organizing, and maintaining regulatory documents within applicable regulatory authority submissions portals such as CTIS, FDA eGateway, and CESP. - Coordinating the redaction of confidential information in regulatory documents and liaising with external vendors for redaction services. - Assisting in preparing, formatting, and checking the completeness of documents for regulatory submissions. - Supporting the creation of regulatory submission packages and providing publishing and technical support for submission documents. - Assisting in auditing and reviewing regulatory submissions for accuracy and completeness. - Keeping abreast of evolving regulations and communicating updates to the Regulatory Affairs team. - Maintaining tracking logs for submission timelines, regulatory approvals, and document status. - Assisting with internal audits and inspections by preparing required regulatory documentation. - Mentoring, training, and supervising junior Regulatory Administrators. - Resolving complex issues related to submission document upload, publishing, and system functionality. - Contributing to planning and process improvement for regulatory operations. - Collaborating with cross-functional teams and participating in department meetings to stay informed of regulatory updates. To qualify for this role, you must have a Bachelor's degree or equivalent experience, computer literacy (MS Office/Office 365), fluency in English (written and verbal), and a minimum of 3 years of experience in document management. Preferred qualifications include previous experience in clinical research or regulatory affairs, advanced knowledge of CTIS system, understanding of global regulatory requirements, experience with document management systems, and electronic submission formats. Essential competencies for this role include strong attention to detail, excellent organizational and time management skills, effective communication and interpersonal abilities, teamwork, problem-solving skills, knowledge of regulatory submission processes and guidelines, and adaptability to work in a fast-paced regulatory environment. Please note that any data provided as part of the application will be stored in compliance with our Privacy Policy. For applicants in California, please refer to our CA Privacy Notice. If you require a reasonable accommodation to complete the application process, please contact us at QuestionForHR@precisionmedicinegrp.com. We also caution against fraudulent job offers and emphasize that our organization follows a formal interview process before extending any job offers.,
