Senior Director, Regulatory Affairs (Ad Promo)

Responsibilities

• Manages the Regulatory Promotional reviewers for products who represent Regulatory Affairs on the promotional review committee for preapproval and marketed products.
• This position may require reviewing promotional materials if the company requires it and escalates issues as necessary.
• Ensures compliance with regulatory requirements while supporting the company's strategic promotional objectives.
• Provides guidance on proposed claims for products in development and develops ISI and brief summaries.
• Maintains awareness of regulatory compliance trends, interprets new regulations, guidance documents, and enforcement letters.
• Updates Regulatory Ad Promo staff, review committees, and other company staff regarding regulatory changes.
• Develops or revises procedures needed for regulatory advice and resolution of FDA and Canadian action letters.
• Reviews packages for regulatory advice, leads discussions with FDA OPDP and Canada PAAB, and coordinates companywide regulatory training.
• Represents regulatory affairs in cross-functional prescription product promotional review teams and participates in process development committees.
• Interacts with Legal, Compliance, and Medical Affairs regularly and works with Quality on internal audits and CAPAs as needed.

Qualifications

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

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.

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

About the Role

Join our global diversified pharmaceutical company, dedicated to enriching lives through better health outcomes for our patients. We foster a culture of innovation and collaboration, where your skills and values drive our collective progress and impact.