Senior Manager, Advertising, Promotion and Labeling

Stelle nicht auf LinkedIn

🕒 vor 19 Tagen

🏖️ New Jersey – Remote

🏖️ New Jersey – Remote

💵 $155.180 - $208.369 / Jahr

⏰ Vollzeit

🟠 Senior

👔 Manager

🦅 H1B-Visum-Sponsor

Dieses Unternehmen hat in der Vergangenheit H1B-Visa gesponsert.

👻 Geisterscore 20%

Was es bedeutet: wie wahrscheinlich diese Stelle offen bleibt, ohne dass aktiv eingestellt wird.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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Nestle

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5001 - 10000 Mitarbeiter

🍽️ Lebensmittel & Getränke

🏭 Fertigung

📦 Logistik

Food & Beverage • Manufacturing • Logistics

Nestlé ist ein Schweizer multinationales Unternehmen für Lebensmittel und Getränke, das eine breite Palette abgepackter Lebensmittel und Getränke herstellt und vermarktet, darunter Kaffee, Flaschenwasser, Milchprodukte, Säuglingsnahrung, Süßwaren, Tiefkühlkost und Tierpflegeprodukte. Das Unternehmen vertreibt seine Produkte weltweit über Einzelhandels- und Gastronomiekanäle, betreibt umfangreiche Herstellungs- und Lieferkettenbetriebe und konzentriert sich auf Initiativen in den Bereichen Ernährung, Gesundheit und Wohlbefinden.

Beschreibung

• 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

🎯 Anforderungen

• 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

🏖️ Vorteile

• 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