Senior Manager, Advertising, Promotion and Labeling

Vaga não está no LinkedIn

🕒 Setembro 10

🏖️ New Jersey – Remoto

🏖️ New Jersey – Remote

💵 $155.180 - $208.369 / ano

⏰ Tempo Integral

🟠 Sênior

👔 Gerente

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

👻 Score fantasma 24%

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• Aberta há 63 dias.
• As vagas desta empresa costumam ser preenchidas em 69 dias.

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Nestle

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5001 - 10000 funcionários

🍽️ Alimentos e Bebidas

🏭 Manufatura

📦 Logística

Food & Beverage • Manufacturing • Logistics

A Nestlé é uma multinacional suíça de alimentos e bebidas que produz e comercializa uma ampla gama de alimentos e bebidas embalados, incluindo café, água engarrafada, produtos lácteos, nutrição infantil, confeitaria, alimentos congelados e marcas de cuidados com animais de estimação. A empresa vende seus produtos globalmente através de canais de varejo e serviços de alimentação, opera extensas operações de fabricação e cadeia de suprimentos, e foca em iniciativas de nutrição, saúde e bem-estar.

Descrição

• Own regulatory strategy, review, approval, and governance of promotional, non-promotional, labeling, and artwork materials for assigned pharmaceutical products • Chair or co-chair PRC meetings and document cross-functional review decisions • Review, challenge, and approve materials across 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 properly supported • Provide regulatory positions, options, risk assessments, and escalation pathways • Oversee Veeva PromoMats workflows, approvals, annotations, claim linking, audit trails, and archive readiness • Lead strategic product labeling from target product profile through Company Core Data Sheet, US Prescribing Information, Medication Guide, Patient Information, Instructions for Use, artwork, SPL, and regional implementation • Coordinate implementation of new or revised labeling across promotional materials, 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 timelines • Serve as primary regulatory contact and signatory for FDA promotional submissions, including OPDP and/or CBER APLB interactions • Prepare and submit Form FDA 2253 packages, advisory comment packages, annotated materials, revised materials, and correspondence • Support regulatory submissions intersecting with IND, BLA/NDA, efficacy supplement, labeling supplement, annual report, and launch readiness activities • Monitor health authority feedback, enforcement trends, competitor communications, guidance updates, laws, and regulations • Develop launch and post-launch regulatory review plans • Partner with Marketing and external agencies to support compliant creativity and accelerate approval timelines • Provide regulatory training to Commercial, Medical, field teams, agencies, and vendors • Establish review and submission performance metrics • Develop and implement SOPs, checklists, escalation criteria, and training materials • Integrate acquired products, new indications, mature products, and lifecycle projects into controlled processes • Promote regulatory excellence, inspection readiness, ethical decision making, and business-aligned risk mitigation • Report to the VP & Head of Global Regulatory Affairs Pharma

🎯 Requisitos

• Bachelor’s degree in a scientific, pharmacy, biomedical, regulatory, or related discipline required • 10 or more years of progressive Regulatory Affairs experience in pharmaceutical, biologic, specialty, or branded commercial organizations is strongly preferred • Substantial hands-on experience in advertising, promotion, labeling, or commercial regulatory affairs • Prior working experience with Veeva PromoMats, Veeva RIM, eCTD publishing tools, SPL/artwork workflows, and Microsoft Office tools is mandatory • Experience reviewing and approving promotional and non-promotional materials across 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 • 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 • Strong working knowledge of Microsoft Office Suite • Regulatory Affairs Certification or equivalent professional development preferred • Advanced degree preferred • This position is not eligible for Visa Sponsorship

🏖️ Benefícios

• Performance-based incentives • 401k with company match • Healthcare coverage • Competitive total rewards package • Professional growth and development opportunities • Opportunities to learn from talented colleagues around the globe • Benefits supporting physical, financial, and emotional wellbeing • Inclusive work environment • Accommodation support during the recruitment process

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