Sr. Regulatory Affairs Specialist - Ad/Promo

About the role

This is Prolacta Bioscience’s mission: to save the lives of infants in the NICU by contributing to the growth of the organization and developing professional skills.

Responsibilities

• Review assigned advertising, promotional, labeling, packaging, digital, scientific, educational, technical, and other external-facing materials for regulatory compliance, intended use, claim support, accuracy, balance, and consistency with approved source documents.
• Evaluate proposed claims, benefit statements, graphics, references, disclaimers, comparative language, product positioning, and labeling changes for substantiation, regulatory impact, notification requirements, and escalation needs.
• Prepare, coordinate, track, close out, and archive regulatory notifications, approvals, submissions, review records, claim support, references, and final approved materials in applicable systems.
• Carefully assess regulatory impact, claim support, labeling changes, notification needs, documentation requirements, and compliance risks for commercial, scientific, technical, or customer-facing materials.
• Support improving claim matrices, maintain labeling references, review checklists, submission templates, controlled documents, trackers, and other tools supporting consistent AdProm, labeling, and notification execution.
• Monitor applicable regulations, guidance, enforcement trends, industry practices, and internal learnings; summarize relevant requirements, risks, and process implications for stakeholders.
• Support audits, inspections, and health authority requests related to advertising/promotional materials, labeling, claims, notifications, and supporting documentation.
• Identify recurring review issues, documentation gaps, compliance risks, training needs, and process improvement opportunities within assigned areas.
• Exercise sound independent judgment within established policies, procedures, and assigned scope; manage competing priorities and escalate complex or high-risk issues under management oversight.

Requirements

• Bachelor’s degree in science, nutrition, food science, regulatory affairs, technical, or related discipline required; advanced degree preferred.
• A minimum of 6 years of relevant regulated industry experience in Regulatory Affairs with exposure to advertising/promotional review, labeling, product claims, regulatory notifications, submissions, controlled documentation, or quality/regulatory compliance activities.
• Familiarity with applicable FDA and FTC requirements and guidance, including relevant labeling, infant formula, health product advertising substantiation, and promotional material notification or submission expectations.
• Experience assessing regulatory impact, claim support, labeling changes, notification needs, documentation requirements, and compliance risks for commercial, scientific, technical, or customer-facing materials.
• Experience coordinating cross-functional reviews, resolving comments, maintaining trackers, preparing status updates, and supporting timely completion of review, approval, submission, and record-retention activities.
• Ability to review scientific, technical, quality, manufacturing, operations, and product information to identify support concerns, documentation gaps, regulatory risks, escalation needs, and practical mitigation options.
• Experience with electronic document management, regulatory information management, promotional review, labeling, submission tracking, or document review systems desirable.
• Strong written, verbal, interpersonal, organizational, prioritization, problem-solving, and Microsoft Office skills required.

Qualifications

• Attention to Detail — reviews advertising, promotional, labeling, scientific, technical, and regulatory content for accuracy, consistency, substantiation, traceability, and audit readiness.
• Communication and Collaboration — provides clear comments, rationale, status updates, risk summaries, and practical recommendations while working effectively with Regulatory Affairs, Marketing, Medical/Scientific Affairs, Legal, Quality, Operations, Manufacturing, consultants, and submission support resources.
• Organization and Follow-Through — manages assigned review timelines, routing, trackers, commitments, action items, controlled records, and competing priorities with appropriate oversight.
• Analytical Thinking and Judgment — evaluates claim support, labeling requirements, source documentation, regulatory trends, and process data to identify risks, gaps, mitigation options, and escalation needs.
• Guidance and Continuous Improvement — supports stakeholder onboarding, training, documentation needs, workflow improvements, and process efficiencies within assigned areas.
• Dependability and Adaptability — reliable, accountable, timely, flexible, and effective in managing changing priorities, deadlines, and assigned review, documentation, notification, and improvement activities.
• Integrity — demonstrates honesty, objectivity, and sound ethical judgment in regulatory review and documentation practices.