Responsibilities

• Chair or co-chair PRC meetings for assigned products and ensure cross-functional review decisions are documented, risk-based, and actionable.
• Review, challenge, and approve promotional and non-promotional materials for HCP, patient, consumer, field, trade, payer, booth, website, digital, email, social media, speaker program, training, press, and disease education channels.
• Ensure claims, graphics, headlines, comparative statements, real-world evidence, testimonials, imagery, and references are supported by approved labeling, appropriate evidence, and internal substantiation standards.
• Provide clear regulatory positions with options, pros and cons, and escalation pathways when business objectives and compliance constraints require strategic tradeoffs.
• Maintain oversight of Veeva PromoMats workflows, reviewer assignments, electronic approvals, annotations, claim linking, audit trails, and archive readiness.
• Lead and support strategic product labeling from target product profile through Company Core Data Sheet, US Prescribing Information, Medication Guide, Patient Information, Instructions for Use, carton/container artwork, SPL, and regional implementation.
• Coordinate implementation of new or revised labeling across promotional materials, field training, websites, patient resources, artwork, and vendor-controlled content.
• Partner with CMC, Safety, Medical, Quality, Clinical, Commercial, and Regulatory Operations on change controls, labeling supplements, safety updates, and artwork implementation timelines.
• Monitor labeling-related health authority feedback, enforcement trends, competitor communications, and internal metrics to continuously improve review quality and efficiency.
• Serve as primary regulatory point of contact and signatory for FDA promotional submissions for assigned products, including OPDP and/or CBER APLB interactions as applicable to the product type.

Requirements

• Bachelor’s degree in a scientific, pharmacy, biomedical, regulatory, or related discipline required; advanced degree preferred.
• 10 or more years of progressive Regulatory Affairs experience in pharmaceutical, biologic, specialty, or branded commercial organizations, with substantial hands-on experience in advertising, promotion, labeling, or commercial regulatory affairs is strongly preferred.
• Prior working experience in systems such as Veeva PromoMats, Veeva RIM, eCTD publishing tools, SPL/artwork workflows and Microsoft office tools is mandatory.
• Demonstrated experience reviewing and approving promotional and non-promotional materials, including HCP, patient, consumer, payer, digital, social, field, booth, training, and agency-developed content.
• Strong working knowledge of FDA prescription drug promotion requirements, OPDP and/or CBER APLB expectations, Form FDA 2253 submissions, advisory comment processes, fair balance, claim substantiation, and approved labeling boundaries.
• Experience with labeling development and implementation, including Prescribing Information, Medication Guides, Patient Information, carton/container artwork, SPL, CCDS, labeling supplements, change controls, and commercial launch readiness.
• Experience with Veeva PromoMats, Veeva RIM, eCTD publishing workflows, document management systems, SOPs, training curricula, and audit-ready records.
• Demonstrated ability to lead cross-functional teams, present regulatory options with rationale, influence without authority, and maintain productive relationships with commercial and technical stakeholders.
• Excellent written and verbal communication skills, including ability to write concise regulatory review comments, health authority correspondence, review committee decisions, and executive updates.
• Strong working knowledge of Microsoft Office Suite, including the ability to prepare professional documents, presentations, spreadsheets, and reports.

Preferred

• Regulatory Affairs Certification or equivalent professional development preferred.

Benefits

• 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.