Senior Manager, Advertising, Promotion & Labeling (Remote)

About the role

Reporting to the VP & Head of Global Regulatory Affairs Pharma, the Senior Manager leads the regulatory strategy, review and approval of all promotional, non‑promotional and labeling materials for assigned pharmaceutical products. The role ensures communications are scientifically accurate, truthful, and aligned with business objectives while meeting FDA, legal and compliance standards.

Key responsibilities

• Chair or co‑chair PRC meetings, document cross‑functional decisions and ensure actionable outcomes.
• Review, challenge and approve promotional and non‑promotional materials across HCP, patient, consumer, digital, social, field and booth channels.
• Maintain Veeva PromoMats workflows, reviewer assignments, electronic approvals and audit trails.
• Lead strategic product labeling from core data sheet through US Prescribing Information, medication guides and artwork implementation.
• Prepare and submit Form FDA 2253 packages, draft advisory comment packages and coordinate with Regulatory Operations.
• Provide regulatory training to commercial, medical, field teams and external agencies on label boundaries and fair‑balance requirements.

Required profile

• Bachelor’s degree in a scientific, pharmacy, biomedical or related discipline; advanced degree preferred.
• 10+ years progressive Regulatory Affairs experience in pharma/biologics with hands‑on advertising, promotion and labeling expertise.
• Demonstrated experience reviewing and approving HCP, patient, consumer and digital promotional content.
• Strong knowledge of FDA promotional review processes, Form FDA 2253 and related regulatory submissions.

Required skills

• Veeva PromoMats
• Veeva RIM
• eCTD publishing tools
• SPL/artwork workflow systems
• Microsoft Office suite