[Hiring] Senior Manager, Advertising, Promotion and Labeling @Nestle Operational Services Worldwide SA

Role Description

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
• Truthful, balanced, scientifically accurate, and not misleading
• 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
• 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
• External agencies

The role is accountable for:

• Pragmatic regulatory advice
• Clear risk-based recommendations
• 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 lead and translate label strategy, health authority expectations, and commercial execution needs into compliant, operationally practical solutions across various materials.

Qualifications

• 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
• 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
• Strong working knowledge of FDA prescription drug promotion requirements
• Experience with labeling development and implementation
• Demonstrated ability to lead cross-functional teams
• Excellent written and verbal communication skills
• Strong working knowledge of Microsoft Office Suite

Requirements

• Chair or co-chair PRC meetings for assigned products
• Review, challenge, and approve promotional and non-promotional materials
• Ensure claims, graphics, headlines, and references are supported by approved labeling
• Provide clear regulatory positions with options, pros and cons
• Maintain oversight of Veeva PromoMats workflows
• Lead and support strategic product labeling
• Coordinate implementation of new or revised labeling
• Partner with CMC, Safety, Medical, Quality, Clinical, Commercial, and Regulatory Operations
• Monitor labeling-related health authority feedback
• Serve as primary regulatory point of contact for FDA promotional submissions
• Prepare, coordinate, and submit Form FDA 2253 packages
• Track and interpret health authority comments
• Develop launch and post-launch regulatory review plans
• Partner with Marketing and external agencies early in concept development
• Provide regulatory training to Commercial, Medical, field, agencies, and vendors
• Establish metrics for review cycle time and submission timeliness
• Develop, update, and implement SOPs and training materials
• Ensure acquired products and lifecycle projects are integrated into company systems
• Promote a culture of regulatory excellence and ethical decision making

Benefits

• Performance-based incentives
• Competitive total rewards package
• 401k with company match
• Healthcare coverage
• A broad range of other benefits