POSITION OVERVIEW:Reporting to the VP & Head of Global Regulatory Affairs Pharma, the Senior Manager, Advertising, Promotion and Labeling owns the regulatory strategy, review, approval, and governance of promotional, non-promotional, labeling, and artwork materials for assigned pharmaceutical products. The role ensures that product communications are consistent with the approved Prescribing Information and current company core labeling, are truthful, balanced, scientifically accurate, and not misleading, and are aligned with business objectives without compromising regulatory, legal, medical, safety, or compliance standards.
The incumbent needs to be a hands-on regulatory advertising and promotion leader who can independently approve complex materials, lead PRC/MRL governance, communicate confidently with FDA promotional review groups, translate label changes into commercial implementation plans, and balance compliant risk management with business execution for a pharmaceutical or biologics portfolio. This role requires close partnerships with Marketing, Medical Affairs, Legal, Compliance, Pharmacovigilance, Quality, Technical Operations, Supply, Regulatory Operations, artwork vendors, and external agencies to enable efficient launch readiness and lifecycle management. The role is accountable for pragmatic regulatory advice, clear risk-based recommendations, and timely FDA submissions for final and draft promotional materials, including Form FDA 2253 and advisory comment packages for biologics where applicable.
This position requires a regulatory professional who can also lead and translate label strategy, health authority expectations, and commercial execution needs into compliant, operationally practical solutions across print, digital, field, booth, social, patient, HCP, payer, and scientific exchange materials.
KEY 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.
- Prepare, coordinate, and submit Form FDA 2253 packages, draft advisory comment packages, annotated materials, revised materials, and related correspondence in collaboration with Regulatory Operations.
- Support submissions and regulatory documents where advertising, promotion, labeling, or commercialization considerations intersect with IND, BLA/NDA, efficacy supplement, labeling supplement, annual report, or launch readiness activities.
- Track and interpret health authority comments, untitled or warning letter trends, guidance updates, and applicable laws and regulations affecting promotional and labeling review.
- Develop launch and post-launch regulatory review plans, including promotional material prioritization, final labeling alignment, field training review, booth governance, website readiness, and 2253 submission planning.
- Partner with Marketing and external agencies early in concept development to prevent rework, support compliant creativity, and accelerate approval timelines.
- Provide regulatory training to Commercial, Medical, field, agencies, and vendors on promotional standards, label boundaries, fair balance, claims development, reference use, and digital channel risks.
- Establish metrics for review cycle time, first-pass quality, resubmission frequency, late-stage rework, labeling implementation, and submission timeliness.
- Develop, update, and implement SOPs, working practices, checklists, issue escalation criteria, and training materials for advertising, promotion, labeling, artwork, and agency/vendor governance.
- Ensure acquired products, new indications, mature products, and lifecycle projects are integrated into company systems, review charters, and controlled processes.
- Promote a culture of regulatory excellence, collaborative problem solving, inspection readiness, ethical decision making, and business-aligned risk mitigation.
EXPERIENCE AND EDUCATION REQUIREMENTS:- Bachelor's degree in a scientific, pharmacy, biomedical, regulatory, or related discipline required; advanced degree preferred. Regulatory Affairs Certification or equivalent professional development 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.
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Salary: $155,180.70 to $208,369.00 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
