Senior Regulatory Lead, Advertising & Labeling

Nestle SA; Bridgewater Township (NJ); À distance; USD 155 000 - 208 000; Plein temps

Avantages offerts par ce poste

401k with company match

Healthcare coverage

Performance-based incentives

Résumé du poste

Nestlé Health Science is seeking a Senior Manager, Advertising, Promotion and Labeling, to own regulatory strategy and governance for promotional and labeling materials across a pharmaceutical portfolio. The role ensures truthful, balanced, and compliant communications aligned with labeling and Prescribing Information.

You will partner with Marketing, Medical, Legal, and Quality to enable timely FDA submissions and lifecycle labeling, overseeing PRC governance and Label changes across print,

Qualifications

• Bachelor’s degree in a scientific, pharmacy, biomedical, regulatory, or related discipline required.
• 10+ years of progressive Regulatory Affairs experience in pharma/biologics with advertising/promotion focus preferred.
• Hands-on experience reviewing and approving promotional/non-promotional materials across HCP, patient, consumer, and digital channels.

Responsabilités

• Chair or co-chair PRC meetings and ensure cross-functional review decisions are documented and risk-based.
• Review, challenge, and approve promotional and non-promotional materials for multiple channels including digital, field, and website.
• Ensure claims, graphics, headlines, and references are supported by approved labeling and substantiation.
• Provide regulatory positions with options and escalation pathways when tradeoffs are needed.
• Lead and manage Veeva PromoMats workflows, approvals, and audit trails.
• Prepare and submit Form FDA 2253 packages and advisory comment materials in collaboration with Regulatory Operations.

Connaissances

Regulatory Affairs

Cross-functional Leadership

FDA/OPDP Knowledge

Communication

Regulatory Strategy

Formation

Bachelor’s degree in science/regulatory field

Outils

Veeva PromoMats

Veeva RIM

eCTD publishing tools

SPL/artwork workflows

Microsoft Office

Description du poste

Nestlé Health Science is seeking a Senior Manager, Advertising, Promotion and Labeling, to own regulatory strategy and governance for promotional and labeling materials across a pharmaceutical portfolio. The role ensures truthful, balanced, and compliant communications aligned with labeling and Prescribing Information.

You will partner with Marketing, Medical, Legal, and Quality to enable timely FDA submissions and lifecycle labeling, overseeing PRC governance and Label changes across print,