The posting
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Specialist, Regulatory Operations based in the United States.
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.
Accountabilities:
- 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.
- 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.
- 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.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Why Apply Through Jobgether?
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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