Senior Director, Regulatory Affairs (Ad Promo)

Responsibilities:

• Manage Regulatory Promotional reviewers and represent Regulatory Affairs on the promotional review committee for preapproval and marketed products; review promotional materials and handle escalations as required.
• Provide guidance on proposed claims and development of ISI and brief summaries.
• Monitor regulatory compliance trends; interpret new regulations, guidance documents, and enforcement letters.
• Update Regulatory Ad Promo staff and review committees on changes in the regulatory environment (FDA OPDP, Canada PAAB, and related considerations); develop/revise procedures.
• Review regulatory advice packages; resolve FDA and Canadian action letters; lead discussions with FDA OPDP and Canada PAAB.
• Coordinate ongoing regulatory training on promotional regulatory issues.
• Represent Regulatory Affairs in cross-functional prescription product promotional review teams and participate in process/procedure development.
• Partner with Legal, Compliance, and Medical Affairs; work with Quality on internal audits and CAPAs as needed.

Qualifications:

• Bachelor’s degree in science or health-related discipline required (PhD/MD/MS/PharmD preferred).
• Minimum 10 years of regulatory affairs product advertising/promotion and people management experience required.
• GI experience preferred.

Required/Preferred Skills:

• Broad pharmaceutical industry knowledge.
• Continuous learning and process improvement mindset.
• Detail-oriented; accurate and consistent document review.
• Strong interpersonal skills; ability to influence effectively.
• Teamwork ability.
• Working knowledge of pharmaceutical and device development/approval processes.
• Excellent oral and written communication.

Compensation/Benefits:

• Base pay range: $215K-296K; eligibility for annual bonus or sales incentive plan.
• Benefits include Medical (prescription drug), Dental, Vision, FSAs, 401(k) match, discretionary time off, paid sick time, stock purchase plan, tuition reimbursement, parental leave, short-/long-term disability, life insurance, accidental death & dismemberment, paid holidays, referral bonuses, and employee discounts.