Reg Affairs Assoc. Director

What You'll Do #LI-RV1

The Associate Director/Director, Regulatory Advertising & Promotion is responsible for providing strategic regulatory leadership for promotional materials and external communications across assigned programs or brands. This role ensures that all promotional activities are compliant with FDA regulations, industry guidance, and company policy, while enabling the business to communicate effectively and competitively.

In addition to timely review of materials, the Associate Director/Director is expected to help shape messaging strategy early, anticipate regulatory risk and opportunities, and influence cross-functional partners to drive compliant, compelling communications that enable the business to deliver content and messaging effectively to its stakeholders.

Responsibilities

Strategic Regulatory Leadership

• 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.

• Assess regulatory risk and recommend clear, practical mitigation strategies.

Promotional Review & Governance

• 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

Required

• 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

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• 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

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents

• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)

• Hybrid work model - employees have the autonomy in where and how they do their work 

• Unlimited flexible paid time off - take the time that you need

• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents

• Flex spending accounts & company-provided group term life & disability 

• 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

#LI-TB1