Senior Director, Regulatory Affairs (Ad Promo)

Job Location: Washington, District of Columbia, USA | Boston, Massachusetts, USA | Bridgewater, New Jersey, USA | NewYorkCity, New York, USA | Philadelphia, Pennsylvania, USA | Job Requisition ID: 15511

About the role

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

Responsibilities

• Manages the Regulatory Promotional reviewers for products who represent Regulatory Affairs on the promotional review committee for preapproval and marketed products.
• May review promotional materials if required and handle escalations.
• Ensures compliance with regulatory requirements while meeting company's strategic promotional objectives.
• Provides guidance on proposed claims for products in development and development of ISI and brief summaries.
• Regularly monitors regulatory compliance trends in industry, interprets new regulations, guidance documents and enforcement letters.
• Updates Regulatory Ad Promo staff, review committees and appropriate other company staff regarding changes in the current regulatory environment at FDA's Office of Prescription Drug Promotion (OPDP), Canada Pharmaceutical Advertising Advisory Board (PAAB) and other regulatory considerations.
• Develops or revises procedures as needed.
• Reviews packages for regulatory advice, resolves FDA and Canadian action letters, and leads company discussions with FDA OPDP and Canada PAAB.
• Coordinates companywide ongoing regulatory training on regulatory issues pertaining to promotion of company products.
• Represents regulatory affairs in cross‑functional prescription product promotional review teams as required and participates in development committees for processes and procedures relating to ad promo.
• Interacts regularly with Legal, Compliance and Medical Affairs.
• Works with Quality on internal audits and CAPAs as needed.

Qualifications

• Bachelor’s degree in science or health‑related discipline required (advanced degree PhD, MD, MS, PharmD preferred).
• Minimum 10 years of regulatory affairs product advertising and promotion and people‑management experience required.
• GI experience – preferred.
• Broad knowledge of the pharmaceutical industry.
• Demonstrated ability to contribute to a continuous learning and process improvement environment.
• Detail‑oriented with ability to promptly assess documents for accuracy and consistency.
• Strong interpersonal skills with ability to influence others positively and effectively.
• Ability to work in a team environment.
• Working knowledge of pharmaceutical and device development and approval process.
• Excellent communication skills; both oral and written.

Benefits

• Comprehensive Medical (includes Prescription Drug)
• Dental
• Vision
• Flexible Spending Accounts
• 401(k) with matching company contribution
• Discretionary time off
• Paid sick time
• Stock purchase plan
• Tuition reimbursement
• Parental leave
• Short‑term and long‑term disability
• Life insurance
• Accidental death & dismemberment insurance
• Paid holidays
• Employee referral bonuses
• Employee discounts

Pay

The range of starting base pay for this role is $215,000 – $296,000. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) the annual bonus program or (ii) a sales incentive plan.