Senior Regulatory Operations Specialist

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Oversee the operational execution of global regulatory submissions throughout the development, registration, and post-approval phases.

• Create submission strategies, timelines, dependencies, forecasts, and resource requirements.

• Identify risks and dependencies, propose solutions, and escalate issues that may impact quality, compliance, costs, or timelines.

• Act as the Regulatory Operations representative on submission teams, providing guidance on dossier formats, technical specifications, content readiness, schedules, and deliverables.

• Manage the preparation, publishing, quality review, validation, delivery, and archiving of submissions.

• Track health authority receipts and validation outcomes, addressing any technical challenges that arise.

• Monitor health authority inquiries, correspondence, commitments, and timelines for responses.

• Conduct or supervise document formatting, link management, bookmarks, technical quality assessments, and eCTD lifecycle tasks.

• Maintain submission sequences, document reuse, lifecycle history, active dossiers, regulatory data, product records, and submission statuses.

• Assist with inspections, audits, due diligence, system validation, access controls, audit trails, change management, investigations, corrective actions, and process enhancements.

• Coordinate with external service providers, facilitating vendor onboarding, governance, budgets, invoices, service expectations, and performance evaluation.

• Report on Regulatory Operations metrics, identifying trends, risks, capacity issues, and opportunities for improvement.

• Stay updated on regulatory requirements, data standards, tools, portals, and guidance; develop procedures, templates, training materials, and process instructions.

• Lead or contribute to initiatives focused on system, submission process, departmental enhancements, integration, migration, mergers, acquisitions, and divestitures.

• Utilize approved AI, analytics, and automation tools responsibly, ensuring the protection of regulated information while maintaining human oversight, accuracy, compliance, and record-keeping.

• Offer coaching, practical advice, and knowledge sharing to colleagues, content creators, and business partners.

⛳️ Requirements

• A Bachelor’s degree in life sciences, information management, technology, or a related discipline, or an equivalent combination of education and relevant experience.

• A minimum of 6 to 8 years of experience in the pharmaceutical, biotechnology, or related life sciences regulatory fields, with a strong preference for substantial experience in Regulatory Operations.

• At least 3 years of direct involvement in electronic submission publishing, technical dossier management, or closely related submission delivery activities.

• Experience in supporting global submissions, particularly in the United States and Europe.

• Familiarity with development, marketing applications, and lifecycle submission types, including INDs, CTAs, NDAs, BLAs, MAAs, NDSs, variations, supplements, amendments, annual reports, renewals, and related responses.

• Proficiency in RIM, electronic document management, submission publishing, validation, archiving, and health authority submission systems.

• Experience in coordinating cross-functional submission teams and external service providers in a regulated setting.

• Background in working with validated or otherwise controlled systems and processes.

• Regulatory Affairs Certification is preferred, but not mandatory.

• Understanding of eCTD 4.0, submission standards, data requirements, regulations, guidance, data integrity standards, and electronic record mandates.

• Ability to manage competing priorities, adjust to uncertainty, meet tight deadlines, and work both independently and collaboratively.

• This position is not eligible for Visa Sponsorship.

🏝️ Benefits

• Eligibility for performance-based incentives/bonuses.

• 401(k) plan with company matching.

• Comprehensive healthcare coverage.

• Competitive total rewards package.

• Opportunities for professional growth and dynamic career paths.

• Extensive development opportunities.

• Chance to learn from skilled colleagues worldwide.

• Benefits that promote physical, financial, and emotional well-being.

• Reasonable accommodations available during the recruitment process.