Senior Specialist, Regulatory Operations

Accountabilities:: You will oversee the operational preparation and execution of assigned regulatory submissions, ensuring that documents and submission packages meet applicable technical standards and internal requirements. You will collaborate with cross-functional stakeholders to maintain submission readiness, resolve technical issues, and support continuous improvement across regulatory operations. Manage routine regulatory submissions, including INDs, CTAs, application lifecycle submissions, meeting packages, and responses to health authority requests. Support complex or high-priority filings under the guidance of the responsible Regulatory Operations Submission Manager. Maintain submission plans, content trackers, milestones, delivery dates, and readiness status in collaboration with regulatory leads and project teams. Coordinate with document owners to confirm content handoffs, track outstanding actions, communicate delays, and escalate risks promptly. Prepare submission-ready Word and PDF documents, including formatting, conversion, bookmarking, hyperlinking, and technical quality checks. Compile, publish, and validate eCTD and non-eCTD submission packages using approved tools and current regional specifications. Perform document-level technical quality control, resolve publishing and validation issues, and conduct submission-level quality checks when qualified. Coordinate authorized submission delivery, monitor transmission acknowledgments and delivery status, resolve technical rejections, and archive final records. Create and maintain accurate regulatory information management records in Veeva RIM, including applications, submissions, documents, metadata, milestones, and health authority correspondence. Support RIM workflows, data quality, user issue resolution, system changes, and collaboration with IT, Quality, and system business owners. Provide technical support for promotional submissions, including FDA Form 2253, by coordinating approved content and required documentation. Contribute to regulatory projects through action tracking, meeting follow-up, status reporting, system migrations, user acceptance testing, training, work instruction updates, and process improvements. Requirements: You will bring hands-on regulatory operations experience in the pharmaceutical or biotechnology industry, with a strong understanding of electronic submission preparation, publishing standards, and regulatory documentation. Success in this role requires technical precision, effective cross-functional communication, and the ability to manage multiple deliverables independently while maintaining high-quality records and meeting deadlines. Bachelor’s degree in life sciences or a related discipline. Master’s degree in Regulatory Affairs is highly desirable. At least 4 years of regulatory operations experience in the pharmaceutical or biotechnology industry, including 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 quality control. Strong Microsoft Word and Adobe Acrobat skills, including document formatting, PDF preparation, bookmarking, hyperlinking, and troubleshooting. Experience using a regulatory information management system (RIM) or a comparable validated document and submission management platform. Strong attention to detail and a commitment to accurate metadata, documentation, and regulatory records. Ability to organize concurrent deliverables, coordinate with multiple stakeholders, follow up on outstanding actions, and communicate risks promptly. Ability to work independently within assigned responsibilities while collaborating effectively across regulatory and cross-functional teams. Preferred qualifications: Experience with Veeva RIM, Veeva PromoMats, or a comparable promotional content management workflow. Experience supporting submissions to health authorities outside the United States. Familiarity with FDA Form 2253 and post-approval submissions. Experience supporting system migrations, user acceptance testing, work instruction development, or submission project tracking. Benefits: Annual salary range: $122,000–$143,000 USD. Additional compensation: Total compensation may include a bonus, stock, benefits, and other applicable variable compensation. Location-based compensation: Final compensation depends on experience, skills, certifications, work location, and other relevant factors. Remote work: The position is listed as remote within the United States.