DivIHN Integration Inc · 15 hours ago
Regulatory Affairs Specialist
United States
Contract
Remote
Senior Level
5+ years expDivIHN Integration Inc is seeking a Senior Submissions Associate to play a key role in preparing electronic regulatory submissions. This position involves overseeing document formatting, remediation, quality control, and ensuring compliance of eCTD submissions while collaborating with cross-functional teams to manage submission timelines effectively.
ConsultingInformation TechnologySoftware
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, Veeva, 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
Perform hands-on eCTD publishing for investigational submissions across 6–8 ongoing programs
Support submission archiving and compliance documentation
Assist with data migrations into Veeva RIM and related modules (estimated initial 6-month migration window)
Maintain correspondence records and ensure traceability within regulatory systems
Execute document formatting using Microsoft Word with appropriate style guidelines
Support daily submission volumes, especially during peak cycles
Potential engagement with broader Veeva platform functions (Medical Affairs, additional modules) as systems expand
Qualification
Required
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 within 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 Veeva 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 skill is a plus
Very strong interpersonal skills and ability to build relationships with cross-functional teams
Superior knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (PDF Tools, Toolbox, 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 Veeva Submisison/Submission Archive desirable
Strong knowledge of StartingPoint (or similar eCTD authoring) templates
Demonstrated project management, organizational, and planning skills
Ability to excel at multi-tasking, maintain strong attention to detail, and remain result driven to consistently meet deadlines
Ability to work independently with minimal supervision, as well as work in a team environment with changing timelines and priorities
Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines
Strong understanding of the internal and external interdependencies among submission activities that impact the schedule or quality of a submission to proactively manage these interdependencies, ensuring that submission goals are met in a timely manner and uphold the highest standards of quality
Hands-on eCTD publishing experience (recent—within the past 12 months)
Experience using Lorenz DocuBridge v5 (or similar—transferable)
Strong Adobe Acrobat PDF tools competency
Advanced Microsoft Word formatting (styles, templates, technical document structure)
Preferred
Experience using DXC Toolbox / ISI Toolbox (Preferred)
Experience with archiving processes and submission logging (preferred)
Exposure to Veeva RIM preferred (or other EDMS systems)
5–7 years Regulatory Operations experience strongly preferred
Degree required (Bachelor's preferred; Associate considered)
Previous experience in pharma, biotech, or regulatory publishing environment highly beneficial
Experience working with external publishing vendors desired
Company
DivIHN Integration Inc
DivIHN (‘Divine’) has served as a holistic Technology Consulting entity since 2002, committed to Client Success & Transformation.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Herald Ignatius Manjooran
Founder and CEO
J
John Sinkus
Senior Advisor
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