Senior Specialist, Regulatory Operations

Overview of Role:

The Senior Specialist, Regulatory Operations provides hands-on technical preparation and publishing of regulatory submissions, including eCTD packages, and supports submissions to assigned health authorities. The role manages the operational execution of assigned routine submissions and supports larger or complex filings under another Regulatory Operations Submission Manager (RSM). This position also prepares submission-ready documents, follows up on content readiness and milestones, maintains accurate Veeva RIM records, and supports submission-related projects and system activities.

Role and Responsibilities:

Submission preparation and execution

• Serve as the assigned RSM for routine IND, CTA, application lifecycle, meeting, and Health Authority response submissions. Support complex or high-priority filings under the direction of the assigned RSM.

• Maintain assigned submission plans, content trackers, deliverable dates, and readiness status with the Regulatory Lead and project team. Follow up with Document Owners on expected handoffs, document status, and open actions; provide updates and escalate risks to the Regulatory Lead and, when applicable, the lead RSM.

• Prepare submission-ready Word and PDF documents, including formatting, conversion, bookmarks, hyperlinks, and technical checks. Identify content changes needed after handoff and route them to the Document Owner and Regulatory Lead for review and reapproval.

• Compile, publish, and validate eCTD and non-eCTD packages using approved tools and current regional specifications. Perform document-level technical QC, resolve publishing or validation findings with responsible stakeholders, and support global submission delivery as assigned.

• When qualified and independent of package preparation, perform submission-level QC for packages prepared by others. For assigned submissions, confirm technical readiness, transmit or deliver only after Regulatory Lead authorization, track acknowledgments or delivery status, resolve technical rejections, and archive final records.

RIM and cross-functional support

• Create and maintain accurate application, regulatory objective, submission, document, metadata, milestone, and Health Authority correspondence records in Veeva RIM. Support workflows, data quality, user issue triage, and assigned system changes in coordination with the RIM business owner, IT, and Quality.

• Provide technical support for promotional submissions, including Form FDA 2253, when assigned. Coordinate with the Regulatory Lead, promotional content owners, and PromoMats users to obtain approved versions and required package materials.

• Support submission-related projects through action tracking, meeting follow-up, and status reporting. Participate in assigned RIM migration, user acceptance testing, training, work instruction updates, and process improvements; perform other related duties as assigned.

Required Qualifications

• Bachelor's degree in life sciences or a related discipline. Master’s in Regulatory Affairs Highly Desired.

• A minimum of 4 years of Regulatory Operations experience in pharmaceutical or biotechnology, including hands-on document preparation, eCTD publishing, and submission support.

• Working knowledge of eCTD lifecycle management, applicable FDA and ICH technical standards, publishing validation, and document- and submission-level technical QC.

• Strong Microsoft Word and Adobe Acrobat skills, including document formatting, PDF preparation, bookmarking, hyperlinking, and troubleshooting.

• Experience using a RIM or comparable validated document and submission management system, with attention to accurate metadata and records.

• Ability to organize concurrent deliverables, follow up across functions, communicate risks promptly, and work independently within assigned responsibilities.

Preferred Qualifications

• Experience with Veeva RIM, Veeva PromoMats, or a comparable promotional content workflow.

• Experience supporting submissions outside the United States or preparing Form FDA 2253 and postapproval submissions.

• Experience with system migration, user acceptance testing, work instructions, or submission project tracking.