Senior Specialist, Regulatory Operations

As a Senior Specialist, Regulatory Operations, you will play a key role in preparing, publishing, and delivering high-quality regulatory submissions that support the development of innovative oncology therapies. You will manage routine submissions and contribute to complex regulatory filings, ensuring accuracy, technical compliance, and timely delivery. Working closely with regulatory, clinical, quality, and technology teams, you will coordinate submission milestones and maintain reliable regulatory records. You will also help improve submission processes, support regulatory information management systems, and strengthen operational efficiency across global programs. This remote opportunity is suited to a detail-oriented regulatory professional who combines technical publishing expertise with strong organizational skills and a commitment to advancing treatments for patients with serious unmet medical needs.

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.

• 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.