POSITION OVERVIEW:The Senior Regulatory Operations Specialist is an experienced individual contributor who plans, coordinates, publishes, delivers, and maintains global regulatory submissions. The role works with Regulatory Affairs, content owners, technology teams, and external providers to deliver accurate, compliant, and timely dossiers across development, registration, and post-approval activities.
The role also maintains reliable regulatory information, documents, and submission records in approved systems. Responsibilities include supporting inspection readiness, performance reporting, process improvement, and the appropriate use of approved AI and automation tools in line with company controls, data protection, and human review requirements.
KEY RESPONSIBILITIES:- Global Submission Planning and Delivery
- Lead the operational delivery of assigned global regulatory submissions across development, registration, and post-approval lifecycle stages.
- Develop submission plans, timelines, dependencies, forecasts, and resource needs with Regulatory Leads and cross-functional contributors.
- Identify risks and critical dependencies, recommend solutions, and escalate issues that may affect quality, compliance, cost, or timing.
- Represent Regulatory Operations on submission teams and advise on dossier format, technical requirements, content readiness, schedules, and deliverables.
- Coordinate submission preparation, publishing, quality review, validation, delivery, and archiving.
- Monitor health-authority receipts and validation results and coordinate resolution of technical issues.
- Track health-authority questions, correspondence, commitments, and response timelines.
- Publishing and Dossier Lifecycle Management
- Perform or oversee document formatting, links, bookmarks, technical quality checks, and eCTD lifecycle activities.
- Maintain accurate submission sequences, document reuse, lifecycle history, and active dossiers.
- Stay current on submission standards and data requirements, including eCTD 4.0, and assess their operational impact.
- Confirm that literature references and other third-party content are cleared and ready for submission, when applicable.
- Regulatory Information Management and Data Stewardship
- Store, track, reconcile, transfer, and archive submissions, approvals, correspondence, commitments, and related records in approved systems.
- Maintain accurate and traceable regulatory data, product records, document details, and submission status in regulatory information and document management systems.
- Monitor data quality, correct issues, assess the effects of changes, and support consistent data standards across connected systems.
- Support inspections, audits, and due diligence by retrieving records, showing traceability, and answering operational questions.
- Compliance, Quality, and Controlled Systems
- Follow applicable regulations, guidance, company procedures, data integrity standards, and electronic record requirements.
- Support system validation, access controls, audit trails, change control, and periodic reviews for regulatory technology platforms.
- Support investigations, root-cause analysis, corrective actions, lessons learned, and lasting process improvements.
- Maintain inspection-ready documentation and complete required training within established timelines.
- Support business continuity, submission contingency planning, and peak-workload capacity management.
- Vendor, Financial, and Performance Management
- Coordinate external service providers, including assigning work, aligning timelines, reviewing quality, resolving issues, and monitoring performance.
- Support vendor onboarding, governance, budgets, invoices, service expectations, and follow-up actions, as assigned.
- Report Regulatory Operations metrics and identify trends, risks, capacity constraints, and improvement opportunities.
- Process Excellence, Regulatory Intelligence, and Training
- Monitor changes in submission requirements, data standards, regulatory tools, health-authority portals, and guidance, and assess their business impact.
- Develop and maintain procedures, work instructions, templates, training materials, and process guidance.
- Lead or contribute to system, submission-process, and department improvement initiatives using critical thinking, root-cause analysis, and data-informed decision-making.
- Provide coaching, practical guidance, and knowledge sharing to colleagues, content authors, and business partners.
- Support system or organizational integrations, due diligence, divestitures, mergers, acquisitions, and data migrations, as applicable.
- Responsible Use of AI and Automation
- Use company-approved AI, analytics, and automation tools for appropriate Regulatory Operations tasks and follow established procedures.
- Assess proposed uses based on purpose, business value, risk, data sensitivity, regulatory impact, and the level of human review needed.
- Review AI-assisted work for accuracy, completeness, consistency, and appropriate use before finalizing it.
- Protect confidential, personal, proprietary, and regulated information when using AI or cloud-based tools.
- Support required controls for AI-enabled tools used in regulated work, including validation, access, changes, vendor oversight, performance checks, and recordkeeping.
- Recognize and reduce risks such as inaccurate or biased results, inappropriate data exposure, limited transparency, changing performance, security threats, and intellectual-property concerns.
- Encourage responsible use of digital tools while preserving expert judgment, data integrity, compliance, and inspection readiness.
EXPERIENCE AND EDUCATION REQUIREMENTS:- Bachelor's degree in life sciences, information management, technology, or a related field, or an equivalent combination of education and relevant experience.
- At least 6 to 8 years of pharmaceutical, biotechnology, or related life sciences regulatory experience, including substantial experience in Regulatory Operations is strongly preferred.
- At least 3 years of direct experience in electronic submission publishing, technical dossier management, or closely related submission-delivery activities.
- Demonstrated experience supporting global submissions, including the United States and Europe; experience with Canada, the United Kingdom, Switzerland, or other markets is preferred.
- Experience with relevant development, marketing-application, and lifecycle submission types, such as INDs, CTAs, NDAs, BLAs, MAAs, NDSs, variations, supplements, amendments, annual reports, renewals, and related responses, as applicable to the company portfolio.
- Experience with RIM, electronic document management, submission publishing, validation, archiving, and health-authority submission systems.
- Experience coordinating cross-functional submission teams and external service providers in a regulated environment.
- Experience working with validated or otherwise controlled systems and processes.
- Regulatory Affairs Certification is preferred but not required.
SKILLS:- Submission leadership and disciplined project execution.
- Critical thinking, root-cause analysis, and sound judgment.
- Risk identification, prioritization, mitigation, and escalation.
- Data stewardship and attention to detail.
- Stakeholder, vendor, and relationship management.
- Clear written, verbal, and interpersonal communication.
- Ability to influence without direct authority and work effectively in a matrixed environment.
- Ability to manage multiple priorities, adapt to ambiguity, and meet demanding timelines.
- Continuous-improvement mindset, learning agility, and digital literacy.
- Ability to work independently while contributing collaboratively to team objectives.
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Salary: $86,575.50 to $123,298.00 per year
Bonus Eligibility: Yes
The pay range provided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities as well as geographic location. It is not typical for an individual to be hired at top of range.
Nestlé offers performance-based incentives and a competitive total rewards package, which includes a 401k with company match, healthcare coverage and a broad range of other benefits. Incentives and/or benefit packages may vary depending on the position. Learn more at https://www.nestlejobs.com/nestle-in-the-us-benefits
