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.