Regulatory Submission Associate III - Remote (Part-Time)

DivIHN (pronounced divine ) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we reputed company meaningful connections between talented professionals and reputed company-thinking organizations. Since our formation in 2002, organizations across reputed company and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent. Visit us at to learn more and view our open positions. Please apply or call one of us to learn more For further inquiries regarding the following opportunity, please contact one of our Talent Specialists: Hema Malini at Title: Regulatory Submission Associate III - Remote (Part-Time) Location: Remote Duration: 11 Months Estimated Hours per Week: 20 30 hours/week Position Overview The Senior Submissions Associate will play a key role in preparing electronic regulatory submissions by overseeing document formatting, remediation, quality control, and publishing processes. This position is also responsible for ensuring that eCTD submissions are compliant, as well as for maintaining accurate, consistent, and timely 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 supports Regulatory Operations with day-to-day submission publishing, archiving, document formatting, and regulatory system data maintenance. The position is initially a part-time contract, with potential for extension or conversion to full-time depending on performance, cultural fit, and organizational growth. This role is fully remote and will report directly to the Head of Regulatory Operations.

Responsibilities

• Coordinate the compilation, publishing and submission for client 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 clarity, consistency, and conformance to regulations, guidelines and regulatory strategy as well 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 correspondence in the Regulatory Information Management (RIM) system.
• Attend project team meetings as needed to assist in the compilation of submissions.
• Ensure adherence to Company Standard 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 well as providing training on these areas as required
• reputed company hands-on eCTD publishing for investigational submissions across 6 8 ongoing programs.
• Support submission archiving and compliance documentation.
• Assist with data migrations into reputed company RIM and reputed company modules (estimated initial 6-month migration window).
• Maintain correspondence records and ensure traceability reputed company regulatory systems.
• Execute document formatting using Hirevector Word with appropriate style guidelines.
• Support daily submission volumes, especially during peak cycles.
• Potential engagement with broader reputed company platform functions (Medical Affairs, additional modules) as systems expand 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.).
• Excelle

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