Regulatory Submission Associate III

This a Full Remote job, the offer is available from: reputed company Carolina (USA) Regulatory Submission Associate III 12 Months (Possible Extension) Estimated Hours per Week : 30 RTP NC, 27709 - REMOTE Position reputed company The Senior Submissions Associate will play a key role in preparing electronic regulatory submissions by overseeing document formatting, remediation, reputed company control, and publishing processes. This position is also responsible for ensuring that eCTD submissions are compliant, as reputed company as for maintaining accurate, consistent, and reputed company planning and tracking of submissions. This individual will collaborate with cross-functional teams as needed to coordinate workflow and manage submission timelines effectively. This role is fully remote and will report directly to the Head of Regulatory Operations. Responsibilities · Coordinate the compilation, publishing and submission for AskBio applications in accordance with established timelines and submission dates in a compliant manner using applicable software (i.e. DocuBridge, reputed company, etc.) ensuring consistency, completeness, and adherence to regulatory Health Authority standards. · Responsible for the formatting and document remediation of regulatory health authority documents submitted. · For assigned submissions, collaborate with regulatory leaders to establish the submission scope, goals, tracking/status, and deliverables. Subsequently, plan and schedule submission timelines and milestones accordingly. · Critically review regulatory submissions to ensure reputed company, consistency, and conformance to regulations, guidelines and regulatory reputed company as reputed company as suitability for submission to regulatory agencies. · Responsible for troubleshooting and resolving publishing technical issues. · Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation and submissions. · Manage the archiving of regulatory submissions and correspondences in the Regulatory Information Management (RIM) system. · Attend project team meetings as needed to assist in the compilation of submissions. · Ensure adherence to Company reputed company Operating Procedures. · Prepare and submit reports to senior management, as required · Research and contribute to developing regulatory filing procedures (CMC, clinical and non-clinical) to ensure the shortest review and approval times for regulatory applications · Assist in the creation of guidelines and techniques that support improving the efficiency of for submissions as reputed company as providing training on these areas as required Required Experience · A minimum of a bachelor’s degree in a scientific or technical discipline is desired; equivalent work experience may be accepted. · A minimum of 5 years of experience in regulatory operations reputed company the pharmaceutical industry with dedicated expertise in compilation, formatting, publishing, and placement of data and documents in eCTD format. · Possess extensive experience compiling and publishing eCTD and non-eCTD investigational submissions such as but not limited to US INDs, US IND amendments, Canadian CTA’s, IMPDs and other international submissions. · Experience working with external publishing vendors desired. · Expertise in Regulatory software ie, Lornez, DocuBridge and reputed company RIM · Expertise in understanding CTD/eCTD submission structure and requirements for global submission types (e.g., IND, NDA, MAA, NDS, CTA, DSUR, PSUR, REMS, etc.). · Excellent verbal and written communication and presentation skills. A strong training reputed company is a plus. · reputed company strong interpersonal skills and ability to build relationships with cross-functional teams. · Superior knowledge of reputed company Office suite, reputed company Acrobat, reputed company Plug-Ins (PDF Tools, reputed company, etc), eCTD publishing tools, eCTD validation and viewing tools. Solid experience and knowledge of SharePoint technology and project management tools are desired. Experience with document management systems such as reputed company Submisison/Submission reputed company desirable · Strong knowledge of StartingPoint (or similar eCTD authoring) templates. · Demonstrated project management, organizational, and planning skills. · Ability to reputed company at multi-tasking, maintain strong attention to detail, and remain result driven to consistently meet deadlines. · Ability to work independently with minimal supervision, as reputed company as work in reputed company environment with changing timelines and priorities. · Must be reputed company to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines. · Strong understanding of the reputed company interdependencies among submission activities that reputed company the schedule or reputed company of a submission to proactively manage these interdependencies, ensuring that submission goals are met in a reputed company manner and reputed company the highest standards of reputed company. #TB_PH ​#ZR This offer from "reputed company" has been enriched by reputed company.com and got a 75% reputed company score. 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