Associate Director / Director, Regulatory Advertising and Promotion
Scorpion Therapeutics, San Francisco, CA, United States
Associate Director/Director, Regulatory Advertising & Promotion
Responsible for providing strategic regulatory leadership for promotional materials and external communications across assigned programs or brands. This role ensures all promotional activities are compliant with FDA regulations, industry guidance, and company policy while enabling the business to communicate effectively and competitively.
Responsibilities
Serve as the Lead for assigned products (commercial and/or pipeline) in Ad Promo regulatory matters.
Provide proactive guidance on promotional strategy, claims development, and risk positioning.
Partner with Commercial, Medical, Legal, and Clinical teams to align messaging with labeling and data.
Interpret and apply FDA regulations, OPDP guidance, enforcement trends, and industry standards to business initiatives.
Assess regulatory risk and recommend clear, practical mitigation strategies.
Lead review and approval of promotional materials through the Medical, Legal and Regulatory review committee (MLR).
Ensure materials are accurate, balanced, and supported by substantial evidence.
Provide strategic direction on disease awareness, HCP and patient materials, digital content, and launch campaigns.
Support advisory boards, speaker programs, and field training materials as needed.
Contribute to development and refinement of internal SOPs and review processes.
Partner with Regulatory Labeling to ensure promotional claims align with approved labeling and clinical data.
Anticipate labeling implications for promotional planning, especially during launch readiness.
Support development of core claims documents and messaging frameworks.
Monitor FDA enforcement actions and emerging trends.
Support responses to OPDP inquiries or regulatory questions related to promotional materials.
Contribute to inspection readiness activities related to promotional review processes.
Location This role requires onsite presence at the San Francisco office.
Required Qualifications
Advanced scientific degree (PharmD, PhD, MD) or equivalent.
8+ years of pharmaceutical experience with 5+ years of relevant ad‑promo experience.
Deep understanding of FDA promotional regulations, OPDP expectations, and relevant guidance documents.
Experience supporting commercial launches and/or late‑stage development programs.
Demonstrated ability to influence cross‑functional stakeholders in a matrixed environment.
Preferred Qualifications
Experience in rare disease or specialty therapeutics.
Key Competencies
Strategic thinker: balances compliance with business enablement.
Sound judgment: makes clear, defensible decisions under ambiguity.
Influence without authority: navigates cross‑functional dynamics effectively.
Risk calibration: knows when to hold firm and when to flex.
Clear communicator: delivers direct, actionable guidance.
Demonstrated curiosity and adaptability in adopting AI‑powered tools and technologies.
Impact This role directly shapes how the organization communicates its science and value to healthcare professionals and patients. The Associate Director/Director is a critical safeguard for regulatory compliance and a strategic partner to the business during growth and launch phases.
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Responsibilities
Serve as the Lead for assigned products (commercial and/or pipeline) in Ad Promo regulatory matters.
Provide proactive guidance on promotional strategy, claims development, and risk positioning.
Partner with Commercial, Medical, Legal, and Clinical teams to align messaging with labeling and data.
Interpret and apply FDA regulations, OPDP guidance, enforcement trends, and industry standards to business initiatives.
Assess regulatory risk and recommend clear, practical mitigation strategies.
Lead review and approval of promotional materials through the Medical, Legal and Regulatory review committee (MLR).
Ensure materials are accurate, balanced, and supported by substantial evidence.
Provide strategic direction on disease awareness, HCP and patient materials, digital content, and launch campaigns.
Support advisory boards, speaker programs, and field training materials as needed.
Contribute to development and refinement of internal SOPs and review processes.
Partner with Regulatory Labeling to ensure promotional claims align with approved labeling and clinical data.
Anticipate labeling implications for promotional planning, especially during launch readiness.
Support development of core claims documents and messaging frameworks.
Monitor FDA enforcement actions and emerging trends.
Support responses to OPDP inquiries or regulatory questions related to promotional materials.
Contribute to inspection readiness activities related to promotional review processes.
Location This role requires onsite presence at the San Francisco office.
Required Qualifications
Advanced scientific degree (PharmD, PhD, MD) or equivalent.
8+ years of pharmaceutical experience with 5+ years of relevant ad‑promo experience.
Deep understanding of FDA promotional regulations, OPDP expectations, and relevant guidance documents.
Experience supporting commercial launches and/or late‑stage development programs.
Demonstrated ability to influence cross‑functional stakeholders in a matrixed environment.
Preferred Qualifications
Experience in rare disease or specialty therapeutics.
Key Competencies
Strategic thinker: balances compliance with business enablement.
Sound judgment: makes clear, defensible decisions under ambiguity.
Influence without authority: navigates cross‑functional dynamics effectively.
Risk calibration: knows when to hold firm and when to flex.
Clear communicator: delivers direct, actionable guidance.
Demonstrated curiosity and adaptability in adopting AI‑powered tools and technologies.
Impact This role directly shapes how the organization communicates its science and value to healthcare professionals and patients. The Associate Director/Director is a critical safeguard for regulatory compliance and a strategic partner to the business during growth and launch phases.
#J-18808-Ljbffr