Reg Affairs Assoc. Director

What You'll Do

• Serve as the Ad Promo regulatory lead for assigned products (commercial and/or pipeline).
• 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.
• Audit regulatory risk and recommend clear, practical mitigation strategies.

Responsibilities

• Strategic Regulatory Leadership
• 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.
• Labeling & Claims Strategy
• 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.
• Inspection & Enforcement Readiness
• 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.

Where You'll Work

This role requires onsite presence at our San Francisco office.

Who You Are

• Advanced scientific degree (PharmD, PhD, MD) or equivalent.
• 8+ years of pharmaceutical experience with 5+ years plus 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

• Experience in rare disease or specialty therapeutics.

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.
• You have 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.

Rewarding Those Who Make the Mission Possible

• Market leading compensation
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities

Salary

$190,000 - $225,000 USD