Senior Manager, Advertising, Promotion and Labeling

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Take charge of the regulatory strategy, evaluation, approval, and governance of promotional, non-promotional, labeling, and artwork materials for designated pharmaceutical products.

• Lead or co-lead PRC meetings and document decisions made during cross-functional reviews.

• Assess, question, and authorize materials across various channels including HCP, patient, consumer, field, trade, payer, booth, website, digital, email, social media, speaker program, training, press, and disease education.

• Ensure that claims, graphics, headlines, comparative statements, real-world evidence, testimonials, imagery, and references are adequately supported.

• Provide regulatory stances, options, risk evaluations, and escalation pathways.

• Supervise Veeva PromoMats workflows, approvals, annotations, claim linking, audit trails, and readiness for archiving.

• Spearhead strategic product labeling from target product profile through to Company Core Data Sheet, US Prescribing Information, Medication Guide, Patient Information, Instructions for Use, artwork, SPL, and regional implementation.

• Coordinate the implementation of new or updated labeling across promotional materials, training, websites, patient resources, artwork, and vendor-controlled content.

• Collaborate with CMC, Safety, Medical, Quality, Clinical, Commercial, and Regulatory Operations on change controls, labeling supplements, safety updates, and timelines for artwork.

• Act as the 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 related correspondence.

• Assist with regulatory submissions related to IND, BLA/NDA, efficacy supplements, labeling supplements, annual reports, and launch readiness efforts.

• Monitor feedback from health authorities, enforcement trends, competitor communications, guidance updates, laws, and regulations.

• Develop regulatory review plans for product launches and post-launch activities.

• Collaborate with Marketing and external agencies to facilitate compliant creativity and expedite approval timelines.

• Provide regulatory training for Commercial, Medical, field teams, agencies, and vendors.

• Establish metrics for review and submission performance.

• Create and implement SOPs, checklists, escalation criteria, and training materials.

• Integrate acquired products, new indications, mature products, and lifecycle projects into controlled processes.

• Foster regulatory excellence, inspection readiness, ethical decision-making, and risk mitigation aligned with business objectives.

• Report to the VP & Head of Global Regulatory Affairs Pharma.

⛳️ Requirements

• A Bachelor’s degree in a scientific, pharmacy, biomedical, regulatory, or related field is required.

• A minimum of 10 years of progressive experience in Regulatory Affairs within pharmaceutical, biologic, specialty, or branded commercial organizations is strongly preferred.

• Significant hands-on experience in advertising, promotion, labeling, or commercial regulatory affairs.

• Prior experience with Veeva PromoMats, Veeva RIM, eCTD publishing tools, SPL/artwork workflows, and Microsoft Office tools is essential.

• Experience in reviewing and approving promotional and non-promotional materials across HCP, patient, consumer, payer, digital, social, field, booth, training, and agency-developed content.

• Strong understanding of FDA prescription drug promotion requirements, OPDP and/or CBER APLB expectations, Form FDA 2253 submissions, advisory comment processes, fair balance, claim substantiation, and the limits of approved labeling.

• Background in labeling development and implementation, including Prescribing Information, Medication Guides, Patient Information, carton/container artwork, SPL, CCDS, labeling supplements, change controls, and readiness for commercial launch.

• Familiarity with Veeva PromoMats, Veeva RIM, eCTD publishing workflows, document management systems, SOPs, training curricula, and maintaining audit-ready records.

• Ability to lead cross-functional teams, present regulatory options with justification, influence without direct authority, and maintain productive relationships with both commercial and technical stakeholders.

• Excellent written and verbal communication capabilities.

• Strong proficiency with the Microsoft Office Suite.

• Regulatory Affairs Certification or equivalent professional development is preferred.

• An advanced degree is preferred.

• This position does not qualify for Visa Sponsorship.

🏝️ Benefits

• Performance-based incentives.

• 401k with company match.

• Healthcare coverage.

• Competitive total rewards package.

• Opportunities for professional growth and development.

• Chances to learn from talented colleagues around the world.

• Benefits that support physical, financial, and emotional well-being.

• An inclusive work environment.

• Support for accommodations during the recruitment process.