Regulatory Affairs Director

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

📋 Description

• Act as the regulatory lead for advertising promotions related to designated products (both commercial and pipeline).

• Offer proactive insights on promotional strategies, development of claims, and positioning of risks.

• Collaborate with Commercial, Medical, Legal, and Clinical teams to ensure alignment of messaging with labeling and data.

• Analyze and implement FDA regulations, OPDP guidance, enforcement trends, and industry standards to support business initiatives.

• Evaluate regulatory risks and propose clear, practical strategies for mitigation.

• Oversee the review and approval process of promotional materials through the Medical, Legal, and Regulatory review committee (MLR).

• Guarantee that materials are accurate, balanced, and substantiated by significant evidence.

• Provide strategic leadership on disease awareness, materials for healthcare professionals (HCP) and patients, digital content, and launch initiatives.

• Assist with advisory boards, speaker programs, and the creation of field training materials as necessary.

• Help in the creation and improvement of internal standard operating procedures (SOPs) and review processes.

• Collaborate with Regulatory Labeling to ensure that promotional claims comply with approved labeling and clinical data.

• Anticipate labeling consequences for promotional planning, particularly during launch preparations.

• Aid in the development of core claims documents and messaging frameworks.

• Keep track of FDA enforcement actions and emerging trends.

• Assist in responding to OPDP inquiries or regulatory questions associated with promotional materials.

• Participate in inspection readiness activities linked to promotional review processes.

⛳️ Requirements

• Advanced scientific degree (PharmD, PhD, MD) or equivalent qualification.

• Over 8 years of experience in the pharmaceutical industry, including more than 5 years of relevant advertising promotion experience.

• Profound knowledge of FDA promotional regulations, OPDP expectations, and pertinent guidance documents.

• Experience in supporting commercial launches and/or late-stage development initiatives.

• Proven capability to influence stakeholders across functions within a matrixed environment.

🏝️ Benefits

• Market-leading compensation

• 401(k) with employer match

• Employee Stock Purchase Program (ESPP)

• Pre-tax commuter benefits (transit and parking)

• Referral bonus for hired candidates

• Subsidized lunch and parking on in-office days

• 100% employer-paid medical, dental, and vision premiums for you and your dependents

• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)

• Fertility & family-forming benefits

• Expanded mental health support (therapy and coaching resources)

• Hybrid work model with flexibility

• Flexible, “take-what-you-need” paid time off and company-paid holidays

• Comprehensive paid medical and parental leave to care for yourself and your family