Assist the Regulatory Operations Lead in the preparation of regulatory submission documents in compliance with global regulatory requirements for different application types (eg, IND, BLA/sBLA, MAA, CTA, NDS).
Work with Regulatory Operations Lead, subject matter experts, and cross functional departments to analyze and develop processes that support business needs using the Veeva Vault RIM suite (Submissions, and Submissions Archive)
Manage the preparation and submission of preclearance and Form 2253 promotional material submissions to the U.S. FDA through the Office of Prescription Drug Promotion (OPDP), ensuring completeness, accuracy, and compliance with regulatory requirements and timelines, while leveraging Veeva PromoMats to manage promotional materials and submission documentation in alignment with internal review and approval processes.
Partner with Regulatory Affairs and MLR teams to ensure Promotional Review Committee (PRC) approved materials are finalized and submitted in accordance with FDA postmarketing promotional submission requirements.
Format complex Word documents to generate compliant regulatory reports including complicated tables and graphs created in a variety of formats. Maintain the internal regulatory styles template and manage submission templates.
Format, edit, proof, and create bookmarks and hyperlinks according to guidance and internal processes.
Ensure consistency across regulatory submission documents following the regulatory style guide.
Provide technical expertise to cross-functional teams on format, style, and structure of compliant documents for electronic submissions.
Provide input for scheduling and planning submission timelines in collaboration with Regulatory Operations Lead.
Coordinate with external publishing vendors and consultants for on-time delivery of high quality regulatory submissions.
Conduct final review of published submissions to ensure consistency and compliance with regulatory requirements.
Execute regulatory information management tasks including file transfer, storing, tracking, and archiving regulatory submission documents/correspondence.
Participate in the development of Regulatory Operations processes (SOPs, work instructions, guidelines, templates) for preparing submissions and regulatory information management.
Maintain knowledge of global regulatory submission requirements.
Other duties as assigned

Requirements

Bachelor’s degree and 5+ years of experience in Regulatory Operations with specialized skills in electronic submissions.
In depth, hands-on experience and expert level skills in Word processing, formatting, and PDF publishing for electronic submissions.
Relevant experience with electronic document management and publishing systems (eg, Veeva Vault RIM, Veeva Vault PromoMats, Box, SharePoint, Lorenz DocuBridge), eCTD Validation and viewing tools (eg, Lorenz eValidator, EURS Validator) and other formatting, publishing and QC tools (StartingPoint Templates and TRS Toolbox), global regulatory submissions, or other experience directly related to Regulatory Operations.
Proficiency with MS Word and Adobe is a MUST. Knowledge of MS Outlook, PowerPoint, Project, and Excel is a plus.
Committed to producing high quality and timely deliverables.
Work independently and efficiently.
Demonstrate flexibility, patience, and good verbal, written, and interpersonal communication skills.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory submissionselectronic submissionsWord processingformattingPDF publishingeCTD validationdocument managementpublishing systemsquality controlregulatory information management

Soft Skills

communication skillsindependenceefficiencyflexibilitypatienceinterpersonal skillsattention to detailtime managementcollaborationproblem-solving