Regulatory Affairs Operations

Professional Summary:

Self-motivated Regulatory Affairs Professional with over 7+ years of experience in regulatory operations, specializing in regulatory publishing, submission planning, electronic document management, and archiving. Proven track record in preparing, compiling, and submitting eCTD-compliant regulatory dossiers, including INDs, NDAs, BLAs, ANDAs, and IMPDs across multiple regions (FDA, EMA, Health Canada, and MHRA) in alignment with ICH, FDA, and regional regulatory guidelines.

Skilled in using industry-standard tools such as Lorenz DocuBridge, Insight Publisher, ISI Toolbox, Veeva Vault RIM, eCTD Validator, and Extedo for lifecycle management and submission compilation.

Experience managing both initial and lifecycle submissions (amendments, supplements, annual reports, safety updates), ensuring timely and accurate delivery under tight timelines.

Hands-on experience in Module 1 regional requirements and Module 2-5 content formatting, hyperlinking, bookmarking, and publishing-ready outputs.

Adept at performing document QC, version control, and metadata management in accordance with 21 CFR Part 11 compliance and audit-readiness standards.

Proficient in electronic document archiving, SharePoint/Documentum systems, and ensuring alignment with sponsor SOPs and regulatory requirements

Serve as the primary CMC regulatory liaison between internal cross-functional teams (e.g., Manufacturing, Analytical, Quality, and R&D) and external regulatory authorities..

Technical Tools

Insight Publisher, Lorenz DocuBridge, ISI Toolbox, Veeva Vault RIM, Documentum (FirstDoc), eCTDmanager, EURS Validator, GlobalSubmit Validator, SharePoint, Adobe Acrobat, MS Office Suite

Professional Experience:

Senior Regulatory Operations Specialist, Climb Bio, Newton, MA

Feb 2025 to July 2025

Experience with documents for IND, CTA, NDA including preparation and submission of development safety reports (DSUR) and orphan drug designation annual reports

Responsible for all operational tasks associated with or in support of authoring, formatting PDF renditions, bookmarking, hyper-linking with the help of ISI toolbox to ensure eCTD submission readiness of documents.

Collaborated with Accenture on regulatory submission deliverables, ensuring all documents were formatted in accordance with their standardized publishing templates and company-specific style guides.

Ensure all CMC documentation complies with ICH guidelines, FDA regulations (21 CFR), and relevant global regulatory requirements.

Reviewed, edited, and finalized regulatory documents using Accenture-provided templates to maintain consistency and compliance with eCTD publishing requirements.

Utilized Veeva Vault RIM Submissions and Archive to manage submission content, track metadata, and ensure version control and readiness of regulatory documents

Prepare CMC regulatory risk assessments and support regulatory decision-making at various development milestones..

Reg Ops Support, Abcuro Inc, Newton, MA

Sept 2022 to March 2025

Assisting the Regulatory Operations Lead in the preparation of regulatory submission

document in compliance with global regulatory requirements for different application types

(eg, IND, NDA/BLA, MAA, CTA, NDS).

Collaborate with the Regulatory Operations Lead, subject matter experts, and cross-functional teams to analyze current workflows and develop optimized processes that support business needs using the Veeva Vault RIM suite, specifically focusing on Submissions and Submission Archive modules.

Responsibilities include configuring metadata, ensuring compliance with regulatory requirements, and supporting end-to-end document lifecycle management within the system.

Provide global expertise on requirements for electronic document management, submission planning and compilation, publishing, and management of approval information.

Provide administrative management of Veeva from a RegOps perspective, helping to ensure standards are met with documents loaded into Veeva, etc.

Develop and implement global CMC regulatory strategies to support product development, registration, and post-approval changes.

Regulatory Operations Specialist, Allena Pharma, Newton, MA

May 2021 to June 2022.

Publishing of Original Applications, Supplements, Amendments, and Annual Reports for INDs, NDA’s, BLAS, and ANDA’s using Insight Publisher, Lorenz DocuBridge and many other publishing tools in eCTD format.

Coordinate, Compile, publish documents to support all submissions including literature search and references, maintain Submission Log (serial numbers and seq numbers), provide remainder notifications.

Responsible for maintaining chronology, preparation of submission documents, archiving of regulatory submissions, and maintenance of timelines and trackers.

Coordinate with external publishing vendors and consultants for on-time delivery of high-quality regulatory submissions.

Responsible for preparing regulatory submissions for investigational and commercial products in line with ICH, health authority and regional requirements.

Regulatory Operations Specialist, Sanofi, Bridgewater NJ

March 2020 to March 2021

Creating and maintaining study specific QC worksheets and document tracking logs for hard copy/original documents submitted to the TMF for studies designated as paper TMFs.

Prepare, review, compile, finalize and publish error and warning free regulatory submission in Insight Publisher submitted to US FDA for approval to market drugs.

Review and perform QC on compiled, published eCTD submissions, including meta-data, bookmark, and hyperlinks

Organize meetings, track timelines for planned submissions and responses to health authorities

Performs workflows and procedures regarding document tracking, indexing and retrieving, and disseminating information to the regulatory department.

Regulatory Affairs Associate, Iterum therapeutics, Chicago IL.

Feb 2019 to Jan 2020

Reviewed technical documents for accuracy and acceptability for new NDAs amendments (Dossier Submission) supplements, annual reports, and others through eCTD format required for FDA filings.

Assisted in formulating sound strategies in supporting submission goals.

Reviewed the proposed product changes for impact on regulatory status of the product.

Reviewed changes to existing Products and SOPs to define the regulatory requirements.

Supported the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to the company regulatory information concerning current, pending and further approvals and renewals.

Parexel International, Regulatory Affairs Associate, New Jersey

Nov 2017 to Dec 2018

Coordinates, prepares, and reviews all appropriate regulatory submissions (NDA, ANDA, supplements, amendment and Annual Reports) for FDA submissions within a specified time frame in conjunction with the organization.

Extensively well versed with Building complex submission in IP for EU, US.

Meet aggressive deadlines to ensure that regulatory agencies receive timely and quality eCTD submission information.

Preparation and compilation of Module I, II and III for ANDA (eCTD submission).

Perform quality control (QC) of documents published by team members to ensure compliance with applicable guideline documents.

Education: -

Master’s in Computer Science, Silicon Valley University, CA, 2016.

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